Home / Recalls / Abbott Laboratories / Z-1654-2025

Z-1654-2025 Class II Ongoing

Recalled by Abbott Laboratories — Abbott Park, IL

Recall Details

Product Type
Devices
Report Date
April 30, 2025
Initiation Date
March 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

Product Description

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

Reason for Recall

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

Distribution Pattern

Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.

Code Information

UDI-DI 00380740017170 SNs: 35405BG 36034BG 36259BG 36326BG 36327BG 36328BG 36372BG 36545BG 36556BG 36583BG 36588BG 36589BG 54539BG 55361BG 55454BG 55520BG 55814BG 55828BG 72229BG

Other recalls by Abbott Laboratories

  • Z-0961-2026 Class II — Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 (November 13, 2025)
  • Z-0489-2026 Class II — Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalo (September 18, 2025)
  • Z-1653-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1655-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1656-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04 (March 18, 2025)
  • Z-1652-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-2681-2024 Class II — Alinity hq Analyzer, REF: 09P68-01 (June 14, 2024)
  • Z-1476-2024 Class II — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. (February 21, 2024)
  • F-0328-2024 Class II — Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil (October 31, 2023)
  • Z-0682-2024 Class II — ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 (October 19, 2023)