Food, drugs, devices › Abbott Molecular, Inc.
Device recall: Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc. (Des Plaines, IL) initiated this device recall on 6 Dec 2021; FDA lists 1 product record under event 89169, 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 30 Sep 2024. 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
"There is an issue with the installation of updated camera firmware on the system."
Distribution
"Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0463-2022 | Alinity m System, Part No. 08N53-002 | 74 devices | Class II | Terminated | 12 Jan 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: "There is an issue with the installation of updated camera firmware on the system."
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: "Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Sep 2024. "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.