Food, drugs, devices › Abbott Laboratories
Device recall: Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 t
Abbott Laboratories (Santa Clara, CA) initiated this device recall on 18 Sep 2025; FDA lists 1 product record under event 97788, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Abbott Laboratories has 46 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abbott Laboratories, Santa Clara, CA.
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."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0489-2026 | 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 | 833 | Class II | Ongoing | 19 Nov 2025 |
Context
Other enforcement events for Abbott Laboratories
All 46 events for Abbott Laboratories
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.