Food, drugs, devices › Abbott Molecular, Inc.
Device recall: Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Abbott Molecular, Inc. (Des Plaines, IL) initiated this device recall on 12 Oct 2022; FDA lists 1 product record under event 91001, 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Abbott Molecular, Inc. has 20 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 Molecular, Inc., Des Plaines, IL.
Reason for recall
"Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out…"
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0268-2023 | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | 883 units | Class II | Ongoing | 30 Nov 2022 |
Context
Other enforcement events for Abbott Molecular, Inc.
All 20 events for Abbott Molecular, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out…"
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."
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.