Recall Z-1654-2025
Abbott Laboratories · initiated March 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: UDI-DI 00380740017170 SNs: 35405BG 36034BG 36259BG 36326BG 36327BG 36328BG 36372BG 36545BG 36556BG 36583BG 36588BG 36589BG 54539BG 55361BG 55454BG 55520BG 55814BG 55828BG 72229BG
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.
FDA-determined cause: Software change control
Action taken
On March 18, 2025, the firm notified customers through "Urgent Medical Device Correction" letters delivered via FedEx. The letters described the product, problem and actions to be taken. The Customers were instructed to not use expired reagents as this may compromise test accuracy. Always use reagents within their valid expiration dates for all testing procedures. The operator must confirm the container labeling matches the data on the reagent log entry screen dialog box. Quality Controls should be run after any reagent lot number change, maintenance, component replacement, field service action, software change, or calibration. This should be done in accordance with your laboratory s quality control program and regulatory requirements. Complete and return the Customer Reply Form via email: PMS@abbott.com or fax: 1-800-777-0051. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction, provide to them a copy of this letter and retain this letter for your laboratory records. If you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT.
Details
- Recall number
- Z-1654-2025
- Initiated
- March 18, 2025
- Posted by FDA
- April 22, 2025
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 19
- Distribution
- 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…
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1652-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | 03/18/2025Open, Classified |
| Z-1653-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | 03/18/2025Open, Classified |
| Z-1655-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | 03/18/2025Open, Classified |
| Z-1656-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | 03/18/2025Open, Classified |