Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 t
FDA device recall Z-0489-2026 · posted 2025-11-12 · Open, Classified
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- 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.
- Action taken
- 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 letter for your laboratory records. If the problem persists, contact your Abbott representative or Abbott Technical Support (1-800-727-7846) for help to determine whether the inability to communicate is related to this issue.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- GKZ
- Quantity affected
- 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,
- Date initiated
- 2025-09-18
- Date posted
- 2025-11-12
- Location
- Santa Clara, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |