Recall Z-0489-2026 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
| Date | Nov 12, 2025 (initiated Sep 18, 2025) |
| Status | Open, Classified |
| Reason | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. |
| Root cause | Software design |
| Action | On September 18, 2025, Abbott Laboratories issued an "Urgent Medical Device Recall" Notification. Abbott ask consignees to take the following actions: 1. If IG/%IG is above your laboratory established reference range (e.g. greater than 2%), review the results per your laboratory procedures. A manual smear review may need to be performed to confirm the results. 2. Complete and return the Customer Reply Form. 3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4. Please retain this let |
| Quantity | 833 |
| Distribution | Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, |
| FDA record | Open on fda.gov |