Home / Recalls / Illumina, Inc. / Z-1260-2022

Z-1260-2022 Class II

Recalled by Illumina, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
June 22, 2022
Initiation Date
May 3, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
799 instruments

Product Description

illumina Model NextSeq 550 Dx REF 20005715

Reason for Recall

cybersecurity vulnerability

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Code Information

Model Numbers: 20005715 UDI-DI Code: 00816270020125 All Instruments containing Local Run Manager (LRM) Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: NDX550779-15073937 NDX550504-15073937 NDX550732-15073937 NDX550287-15073937 NDX550802-15073937 NDX550691-15073937 NDX550656-15073937 NDX550725-15073937 NDX550736-15073937 NDX550754-15073937 NDX550151-15073937 NDX550996-15073937 NDX550916-15073937 NDX550420-15073937 NDX550715-15073937 NDX550726-15073937 NDX550729-15073937 NDX550730-15073937 NDX550712-15073937 NDX550722-15073937 NDX550660-15073937 NDX550603-15073937 NDX550601-15073937 NDX550595-15073937 NDX550553-15073937 NDX550568-15073937 NDX550579-15073937 NDX550586-15073937 NDX550590-15073937 NDX550561-15073937 NDX550522-15073937 NDX550535-15073937 NDX550563-15073937 NDX550485-15073937 NDX550547-15073937 NDX550552-15073937 NDX550560-15073937 NDX550537-15073937 NDX550531-15073937 NDX550532-15073937 NDX550533-15073937 NDX550501-15073937 NDX550503-15073937 NDX550474-15073937 NDX550445-15073937 NDX550432-15073937 NDX550378-15073937 NDX550369-15073937 NDX550374-15073937 NDX550115-15073937 NDX550370-15073937 NDX550376-15073937 NDX550381-15073937 NDX550361-15073937 NDX550257-15073937 NDX550313-15073937 NDX550288-15073937 15073937NDX550261 NDX550207-15073937 NDX550149-15073937 NDX550138-15073937 NDX550123-15073937 NDX550105-15073937 NDX550136-15073937 NDX550140-15073937 NDX550914-15073937 NDX550968-15073937 NDX550851-15073937 NDX550962-15073937 NDX550763-15073937 NDX550572-15073937 NDX550276-15073937 NDX550389-15073937 NDX550399-15073937 NDX550409-15073937 NDX550414-15073937 NDX550425-15073937 NDX550427-15073937 NDX550348-15073937 NDX550353-15073937 NDX550337-15073937 NDX550338-15073937 NDX550804-15073937 NDX550365-15073937 NDX550839-15073937 NDX550621-15073937 NDX550490-15073937 NDX550580-15073937 NDX550611-15073937 NDX550608-15073937 NDX550594-15073937 NDX550430-15073937 NDX550385-15073937 NDX550310-15073937 NDX550241-15073937 NDX550201-15073937 NDX550169-15073937 NDX550127-15073937 NDX550915-15073937 NDX550899-15073937 NDX550665-15073937 NDX550468-15073937 NDX550321-15073937 NDX550629-15073937 NDX550803-15073937 NDX550852-15073937 NDX550739-15073937 NDX550662-15073937 NDX550609-15073937 NDX550593-15073937 NDX550228-15073937 NDX550174-15073937 NDX550272-15073937 NDX550246-15073937 NDX550248-15073937 NDX550761-15073937 NDX550658-15073937 NDX550540-15073937 NDX550706-15073937 NDX550816-15073937 NDX550363-15073937 NDX550199-15073937 NDX550200-15073937 NDX550193-15073937 NDX550196-15073937 NDX550180-15073937 NDX550182-15073937 NDX550134-15073937 NDX550139-15073937 NDX550760-15073937 NDX550762-15073937 NDX550543-15073937 NDX550341-15073937 NDX550289-15073937 NDX550224-15073937 NDX550209-15073937 NDX550179-15073937 NDX550125-15073937 NDX550973-15073937 NDX550838-15073937 NDX550477-15073937 NDX550260-15073937 NDX550525-15073937 NDX550380-15073937 NDX550211-15073937 NDX550837-15073937 NDX550811-15073937 NDX550657-15073937 NDX550357-15073937 NDX550364-15073937 NDX550349-15073937 NDX550351-15073937 NDX550218-15073937 NDX550738-15073937 NDX550900-15073937 NDX550965-15073937 NDX550457-15073937 NDX550646-15073937 NDX550343-15073937 NDX550316-15073937 NDX550295-15073937 15073937NDX550244 NDX550167-15073937 NDX550210-15073937 NDX550437-15073937 NDX550459-15073937 NDX550489-15073937 NDX550452-15073937 NDX550442-15073937 NDX550443-15073937 NDX550299-15073937 NDX550311-15073937 NDX550308-15073937 NDX550306-15073937 NDX550307-15073937 NDX550314-15073937 NDX550283-15073937 NDX550177-15073937 NDX550853-15073937 NDX550921-15073937 NDX550597-15073937 NDX550339-15073937 NDX550704-15073937 NDX550606-15073937 NDX550526-15073937 NDX550284-15073937 NDX550305-15073937 NDX550237-15073937 NDX550254-15073937 NDX550215-15073937 NDX550110-15073937 NDX550600-15073937 NDX550545-15073937 NDX550807-15073937 NDX550413-15073937 NDX550992-15073937 NDX550820-15073937 NDX550836-15073937 NDX550827-15073937 NDX550342-15073937 NDX550799-15073937 NDX550589-15073937 NDX550234-15073937 NDX550235-15073937 NDX550238-15073937 NDX550239-15073937 NDX550240-15073937 NDX550104-15073937 NDX550894-15073937 NDX550798-15073937 NDX550620-15073937 NDX550614-15073937 NDX550523-15073937 NDX550506-15073937 NDX550461-15073937 NDX550410-15073937 NDX550483-15073937 NDX550354-15073937 NDX550202-15073937 NDX550826-15073937 NDX550486-15073937 NDX550304-15073937 NDX550189-15073937 NDX550163-15073937 NDX550898-15073937 NDX550904-15073937 NDX550670-15073937 NDX550672-15073937 NDX550462-15073937 NDX550111-15073937 NDX550114-15073937 NDX550633-15073937 NDX550377-15073937 O.U.S.: NDX550961-15073937 NDX550959-15073937 NDX550938-15073937 NDX550861-15073937 NDX550774-15073937 NDX550576-15073937 NDX550577-15073937 NDX550623-15073937 NDX550520-15073937 NDX550511-15073937 NDX550507-15073937 NDX550495-15073937 NDX550498-15073937 NDX550309-15073937 NDX550194-15073937 NDX550148-15073937 NDX550160-15073937 NDX550161-15073937 NDX550162-15073937 NDX550953-15073937 NDX550955-15073937 NDX551002-15073937 NDX550907-15073937 NDX550765-15073937 NDX550733-15073937 NDX550663-15073937 NDX550645-15073937 NDX550447-15073937 NDX550431-15073937 NDX550270-15073937 NDX550922-15073937 NDX550596-15073937 NDX550562-15073937 NDX550538-15073937 NDX550469-15073937 NDX550448-15073937 NDX550417-15073937 NDX550416-15073937 NDX550860-15073937 NDX550386-15073937 NDX550895-15073937 NDX550971-15073937 NDX550980-15073937 NDX550822-15073937 NDX550972-15073937 NDX550987-15073937 NDX550948-15073937 NDX550976-15073937 NDX550913-15073937 NDX550936-15073937 NDX550883-15073937 NDX550687-15073937 NDX550835-15073937 NDX550812-15073937 NDX550941-15073937 NDX550878-15073937 NDX550741-15073937 NDX550882-15073937 NDX550743-15073937 NDX550737-15073937 NDX550789-15073937 NDX550886-15073937 NDX550784-15073937 NDX550833-15073937 NDX550880-15073937 NDX550873-15073937 NDX550893-15073937 NDX550892-15073937 NDX550891-15073937 NDX550867-15073937 NDX550782-15073937 NDX550903-15073937 NDX550675-15073937 NDX550794-15073937 NDX550866-15073937 NDX550693-15073937 NDX550750-15073937 NDX550786-15073937 NDX550813-15073937 NDX550795-15073937 NDX550787-15073937 NDX550805-15073937 NDX550831-15073937 NDX550865-15073937 NDX550857-15073937 NDX550819-15073937 NDX550814-15073937 NDX550824-15073937 NDX550742-15073937 NDX550825-15073937 NDX550817-15073937 NDX550653-15073937 NDX550821-15073937 NDX550622-15073937 NDX550796-15073937 NDX550649-15073937 NDX550776-15073937 NDX550793-15073937 NDX550749-15073937 NDX550746-15073937 NDX550642-15073937 NDX550714-15073937 NDX550723-15073937 NDX550713-15073937 NDX550724-15073937 NDX550744-15073937 NDX550728-15073937 NDX550689-15073937 NDX550716-15073937 NDX550682-15073937 NDX550696-15073937 NDX550701-15073937 NDX550718-15073937 NDX550719-15073937 NDX550745-15073937 NDX550661-15073937 NDX550683-15073937 NDX550699-15073937 NDX550694-15073937 NDX550688-15073937 NDX550710-15073937 NDX550680-15073937 NDX550709-15073937 NDX550692-15073937 NDX550679-15073937 NDX550673-15073937 NDX550685-15073937 NDX550684-15073937 NDX550509-15073937 NDX550636-15073937 NDX550678-15073937 NDX550676-15073937 NDX550637-15073937 NDX550630-15073937 NDX550659-15073937 NDX550677-15073937 NDX550635-15073937 NDX550619-15073937 NDX550627-15073937 NDX550647-15073937 NDX550615-15073937 NDX550651-15073937 NDX550625-15073937 NDX550643-15073937 NDX550632-15073937 NDX550605-15073937 NDX550617-15073937 NDX550628-15073937 NDX550624-15073937 NDX550616-15073937 NDX550592-15073937 NDX550602-15073937 NDX550554-15073937 NDX550556-15073937 NDX550516-15073937 NDX550612-15073937 NDX550599-15073937 NDX550598-15073937 NDX550578-15073937 NDX550573-15073937 NDX550574-15073937 NDX550539-15073937 NDX550524-15073937 NDX550541-15073937 NDX550519-15073937 NDX550453-15073937 NDX550544-15073937 NDX550455-15073937 NDX550460-15073937 NDX550512-15073937 NDX550496-15073937 NDX550458-15073937 NDX550510-15073937 NDX550479-15073937 NDX550449-15073937 NDX550438-15073937 NDX550456-15073937 NDX550451-15073937 NDX550319-15073937 NDX550408-15073937 NDX550411-15073937 NDX550328-15073937 NDX550335-15073937 NDX550336-15073937 NDX550394-15073937 NDX550397-15073937 NDX550367-15073937 NDX550323-15073937 NDX550350-15073937 NDX550352-15073937 NDX550245-15073937 NDX550150-15073937 NDX550382-15073937 NDX550259-15073937 NDX550330-15073937 NDX550329-15073937 NDX550296-15073937 NDX550340-15073937 NDX550333-15073937 NDX550332-15073937 NDX550292-15073937 NDX550327-15073937 NDX550326-15073937 NDX550318-15073937 NDX550317-15073937 NDX550252-15073937 NDX550256-15073937 NDX550249-15073937 NDX550266-15073937 NDX550226-15073937 NDX550221-15073937 NDX550263-15073937 NDX550264-15073937 NDX550219-15073937 NDX550197-15073937 NDX550195-15073937 NDX550190-15073937 NDX550154-15073937 NDX550155-15073937 NDX550648-15073937 NDX550631-15073937 NDX550740-15073937 NDX550727-15073937 NDX550731-15073937 NDX550778-15073937 NDX550783-15073937 NDX550791-15073937 NDX550792-15073937 NDX550810-15073937 NDX550815-15073937 NDX550830-15073937 NDX550834-15073937 NDX550823-15073937 NDX550863-15073937 NDX550854-15073937 NDX550906-15073937 NDX550890-15073937 NDX550889-15073937 NDX550887-15073937 NDX550901-15073937 NDX550872-15073937 NDX550870-15073937 NDX550888-15073937 NDX550869-15073937 NDX550871-15073937 NDX550877-15073937 NDX550876-15073937 NDX550850-15073937 NDX550879-15073937 NDX550849-15073937 NDX550881-15073937 NDX550932-15073937 NDX550946-15073937 NDX550949-15073937 NDX550944-15073937 NDX550945-15073937 NDX550947-15073937 NDX550943-15073937 NDX550966-15073937 NDX550969-15073937 NDX550964-15073937 NDX550967-15073937 NDX550982-15073937 NDX550984-15073937 NDX550985-15073937 NDX550979-15073937 NDX550983-15073937 NDX550978-15073937 NDX550977-15073937 NDX550551-15073937 NDX550772-15073937 NDX550757-15073937 NDX550770-15073937 NDX550767-15073937 NDX550690-15073937 NDX550634-15073937 NDX550618-15073937 NDX550638-15073937 NDX550604-15073937 NDX550546-15073937 NDX550559-15073937 NDX550536-15073937 NDX550530-15073937 NDX550402-15073937 NDX550269-15073937 NDX550500-15073937 NDX550470-15073937 NDX550421-15073937 NDX550434-15073937 NDX550435-15073937 NDX550274-15073937 NDX550372-15073937 NDX550358-15073937 NDX550301-15073937 NDX551004-15073937 NDX550950-15073937 NDX550951-15073937 NDX550952-15073937 NDX550912-15073937 NDX550919-15073937 NDX550928-15073937 NDX550845-15073937 NDX550764-15073937 NDX550702-15073937 NDX550664-15073937 NDX550655-15073937 NDX550644-15073937 NDX550558-15073937 NDX550613-15073937 NDX550591-15073937 NDX550567-15073937 NDX550557-15073937 NDX550564-15073937 NDX550429-15073937 NDX550499-15073937 NDX550502-15073937 NDX550494-15073937 NDX550478-15073937 NDX550465-15073937 NDX550433-15073937 NDX550418-15073937 NDX550384-15073937 NDX550379-15073937 NDX550346-15073937 NDX550366-15073937 NDX550371-15073937 NDX550280-15073937 NDX550312-15073937 NDX550297-15073937 NDX550232-15073937 NDX550217-15073937 NDX550158-15073937 NDX550918-15073937 NDX550911-15073937 NDX550302-15073937 NDX550935-15073937 NDX550582-15073937 NDX550735-15073937 NDX550993-15073937 NDX550954-15073937 NDX550931-15073937 NDX550909-15073937 NDX550864-15073937 NDX550859-15073937 NDX550781-15073937 NDX550800-15073937 NDX550785-15073937 NDX550766-15073937 NDX550755-15073937 NDX550759-15073937 NDX550747-15073937 NDX550711-15073937 NDX550698-15073937 NDX550700-15073937 NDX550666-15073937 NDX550650-15073937 NDX550668-15073937 NDX550671-15073937 NDX550652-15073937 NDX550669-15073937 NDX550667-15073937 NDX550654-15073937 NDX550588-15073937 NDX550585-15073937 NDX550584-15073937 NDX550571-15073937 NDX550555-15073937 NDX550491-15073937 NDX550488-15073937 NDX550517-15073937 NDX550493-15073937 NDX550463-15073937 NDX550466-15073937 NDX550508-15073937 NDX550513-15073937 NDX550514-15073937 NDX550436-15073937 NDX550439-15073937 NDX550415-15073937 NDX550422-15073937 NDX550426-15073937 NDX550392-15073937 NDX550419-15073937 NDX550404-15073937 NDX550398-15073937 NDX550395-15073937 NDX550390-15073937 NDX550373-15073937 NDX550325-15073937 NDX550293-15073937 NDX550315-15073937 NDX550282-15073937 NDX550291-15073937 NDX550265-15073937 NDX550231-15073937 NDX550963-15073937 NDX550771-15073937 NDX550751-15073937 NDX550752-15073937 NDX550610-15073937 NDX550566-15073937 NDX550482-15073937 NDX550497-15073937 NDX550473-15073937 NDX550480-15073937 NDX550440-15073937 NDX550450-15073937 NDX550454-15073937 NDX550275-15073937 NDX550368-15073937 NDX550355-15073937 NDX550267-15073937 NDX550268-15073937 NDX550320-15073937 NDX550271-15073937 NDX550279-15073937 NDX550243-15073937 NDX550262-15073937 NDX550253-15073937 NDX550229-15073937 NDX550227-15073937 NDX550185-15073937 NDX550703-15073937 NDX550847-15073937 NDX550250-15073937 NDX550131-15073937 NDX550137-15073937 NDX550842-15073937 NDX550902-15073937 NDX550707-15073937 NDX550848-15073937 NDX550674-15073937 NDX550383-15073937 NDX550198-15073937 NDX550930-15073937 NDX550565-15073937 NDX550640-15073937 NDX550641-15073937 NDX550403-15073937 NDX550929-15073937 NDX551007-15073937 NDX550999-15073937 NDX550926-15073937 NDX550908-15073937 NDX550844-15073937 NDX550855-15073937 NDX550843-15073937 NDX550846-15073937 NDX550768-15073937 NDX550476-15073937 NDX550281-15073937 NDX550481-15073937 NDX550775-15073937 NDX550686-15073937 NDX550681-15073937 NDX550639-15073937 NDX550126-15073937 NDX550769-15073937 NDX550444-15073937 NDX550375-15073937 NDX550960-15073937 NDX550905-15073937 NDX550939-15073937 NDX550818-15073937 NDX550797-15073937 NDX550773-15073937 NDX550626-15073937 NDX550549-15073937 NDX550548-15073937 NDX550492-15073937 NDX550396-15073937 NDX550515-15073937 NDX550423-15073937 NDX550441-15073937 NDX550360-15073937 NDX550359-15073937 NDX550324-15073937 NDX550298-15073937 NDX550334-15073937 NDX550362-15073937 NDX550255-15073937 NDX550278-15073937 NDX550273-15073937 NDX550247-15073937 NDX550188-15073937 NDX550236-15073937 NDX550216-15073937 NDX550192-15073937 NDX550184-15073937 NDX550170-15073937 NDX550133-15073937 NDX550168-15073937 NDX550181-15073937 NDX550153-15073937 NDX550974-15073937 NDX550957-15073937 NDX550934-15073937 NDX550924-15073937 NDX550910-15073937 NDX550721-15073937 NDX550720-15073937 NDX550570-15073937 NDX550569-15073937 NDX550529-15073937 NDX550527-15073937 NDX550528-15073937 NDX550464-15073937 NDX550518-15073937 NDX550505-15073937 NDX550467-15073937 NDX551006-15073937 NDX550925-15073937 NDX550753-15073937 NDX550758-15073937 NDX550697-15073937 NDX550581-15073937 NDX550471-15073937 NDX550407-15073937 NDX550345-15073937 NDX550213-15073937 NDX550220-15073937 NDX550956-15073937 NDX550923-15073937 NDX550832-15073937 NDX550868-15073937 NDX550828-15073937 NDX550734-15073937 NDX550587-15073937 NDX550472-15073937 NDX550251-15073937 NDX550322-15073937 NDX550230-15073937 NDX550927-15073937 NDX550829-15073937 NDX550424-15073937 NDX550412-15073937 NDX550406-15073937 NDX550405-15073937 NDX550920-15073937 NDX550428-15073937 NDX550875-15073937 NDX550858-15073937 NDX550874-15073937 NDX550583-15073937 NDX550705-15073937 NDX550717-15073937 NDX550575-15073937 NDX550708-15073937 NDX550695-15073937 NDX550484-15073937 NDX550550-15073937 NDX550534-15073937 NDX550542-15073937 NDX550475-15073937 NDX550446-15073937 NDX550393-15073937 NDX550400-15073937 NDX550401-15073937 NDX550391-15073937 NDX550344-15073937 NDX550300-15073937 NDX550331-15073937 NDX550303-15073937 NDX550171-15073937 NDX550172-15073937 NDX550173-15073937 NDX550116-15073937 NDX550223-15073937 NDX550225-15073937 NDX550191-15073937 NDX550176-15073937 NDX550152-15073937 NDX550141-15073937 NDX550356-15073937 NDX550607-15073937 NDX550933-15073937 NDX550937-15073937

Other recalls by Illumina, Inc.

  • Z-0884-2026 Class II — Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: Ne (October 28, 2025)
  • Z-1977-2023 Class II — MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) s (April 5, 2023)
  • Z-1976-2023 Class II — NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service s (April 5, 2023)
  • Z-1259-2022 Class II — illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq D (May 3, 2022)
  • Z-0854-2022 Class II — Illumina NextSeq 550Dx, REF: 20005715, CE, IVD (February 22, 2022)
  • Z-0849-2015 Class II — Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universa (November 13, 2014)
  • Z-0850-2015 Class III — Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic (November 6, 2014)
  • Z-2611-2014 Class II — Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSe (July 28, 2014)