Recall Z-1652-2025 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
| Date | Apr 22, 2025 (initiated Mar 18, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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 act |
| Quantity | 2947 |
| 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, Armen |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061667 | CELL-DYN RUBY SYSTEM Abbott Laboratories, Jul 10, 2006 |