Z-2285-2019 Class II Ongoing
FDA device recall Z-2285-2019 was initiated by Luminex Corporation on February 20, 2019 and is designated Class II. Reason for recall: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The im… The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- February 20, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Reason for Recall
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Distribution Pattern
US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
Code Information
Lot numbers & discontinue use by dates for part number 50-10021: AA7546 - 3/9/2019 AA7629 - 4/10/2019