CLASS II Device recall · Reported 12 Jan 2022 · FDA Enforcement Report

Alinity m System recalled by Abbott Molecular

Abbott Molecular is recalling Alinity m System, distributed in 16 states. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAlinity m System, Model 08N53-002 74 impacted serial numbers: 00048, 00076, 00080, 00091, 00105, 00111, 00154, 00155, 00165, 00189, 00191, 00207, 00231, 00232, 00233, 00239, 00252, 00254, 00267, 00280, 00284, 00285, 00288, 00290, 00292, 00293, 00294, 00296, 00302, 00320, 00331, 00343, 00345, 00348, 00357, 00376, 00416, 00418, 00430, 00437, 00466, 00474, 00485, 00486, 00495, 00537, 00540, 00541, 00554, 00566, 00598, 00624, 00629, 00641, 00652, 00656, 00673, 00696, 00697, 00698, 00699, 00700, 00701, 00702, 00703, 00704, 00705, 00706, 00707, 00708, 00709, 00710, 00711, 00712 Impacted UDI numbers: (01)00884999048034(11)190115(21)00048(240)08N53-002 (01)00884999048034(11)190326(21)00076(240)08N53-002 (01)00884999048034(11)190331(21)00080(240)08N53-002 (01)00884999048034(11)190423(21)00091(240)08N53-002 (01)00884999048034(11)190523(21)00105(240)08N53-002 (01)00884999048034(11)190522(21)00111(240)08N53-002 (01)00884999048034(11)190807(21)00154(240)08N53-002 (01)00884999048034(11)190809(21)00155(240)08N53-002 (01)00884999048034(11)190822(21)00165(240)08N53-002 (01)00884999048034(11)191001(21)00189(240)08N53-002 (01)00884999048034(11)191003(21)00191(240)08N53-002 (01)00884999048034(11)191105(21)00207(240)08N53-002 (01)00884999048034(11)200107(21)00231(240)08N53-002 (01)00884999048034(11)200113(21)00232(240)08N53-002 (01)00884999048034(11)200123(21)00233(240)08N53-002 (01)00884999048034(11)200130(21)00239(240)08N53-002 (01)00884999048034(11)200220(21)00252(240)08N53-002 (01)00884999048034(11)200225(21)00254(240)08N53-002 (01)00884999048034(11)200324(21)00267(240)08N53-002 (01)00884999048034(11)200430(21)00280(240)08N53-002 (01)00884999048034(11)200506(21)00284(240)08N53-002 (01)00884999048034(11)200528(21)00285(240)08N53-002 (01)00884999048034(11)200611(21)00288(240)08N53-002 (01)00884999048034(11)200611(21)00290(240)08N53-002 (01)00884999048034(11)200611(21)00292(240)08N53-002 (01)00884999048034(11)200611(21)00293(240)08N53-002 (01)00884999048034(11)200611(21)00294(240)08N53-002 (01)00884999048034(11)200619(21)00296(240)08N53-002 (01)00884999048034(11)200704(21)00302(240)08N53-002 (01)00884999048034(11)200728(21)00320(240)08N53-002 (01)00884999048034(11)200812(21)00331(240)08N53-002 (01)00884999048034(11)200824(21)00343(240)08N53-002 (01)00884999048034(11)200826(21)00345(240)08N53-002 (01)00884999048034(11)200831(21)00348(240)08N53-002 (01)00884999048034(11)200909(21)00357(240)08N53-002 (01)00884999048034(11)200921(21)00376(240)08N53-002 (01)00884999048034(11)201025(21)00416(240)08N53-002 (01)00884999048034(11)201027(21)00418(240)08N53-002 (01)00884999048034(11)201101(21)00430(240)08N53-002 (01)00884999048034(11)201111(21)00437(240)08N53-002 (01)00884999048034(11)201203(21)00466(240)08N53-002 (01)00884999048034(11)201209(21)00474(240)08N53-002 (01)00884999048034(11)201214(21)00485(240)08N53-002 (01)00884999048034(11)201216(21)00486(240)08N53-002 (01)00884999048034(11)201222(21)00495(240)08N53-002 (01)00884999048034(11)210125(21)00537(240)08N53-002 (01)00884999048034(11)210128(21)00540(240)08N53-002 (01)00884999048034(11)210128(21)00541(240)08N53-002 (01)00884999048034(11)210208(21)00554(240)08N53-002 (01)00884999048034(11)210217(21)00566(240)08N53-002 (01)00884999048034(11)210307(21)00598(240)08N53-002 (01)00884999048034(11)210324(21)00624(240)08N53-002 (01)00884999048034(11)210326(21)00629(240)08N53-002 (01)00884999048034(11)210331(21)00641(240)08N53-002 (01)00884999048034(11)210413(21)00652(240)08N53-002 (01)00884999048034(11)210415(21)00656(240)08N53-002 (01)00884999048034(11)210428(21)00673(240)08N53-002 (01)00884999048034(11)210521(21)00696(240)08N53-002 (01)00884999048034(11)210521(21)00697(240)08N53-002 (01)00884999048034(11)210524(21)00698(240)08N53-002 (01)00884999048034(11)210521(21)00699(240)08N53-002 (01)00884999048034(11)210527(21)00700(240)08N53-002 (01)00884999048034(11)210527(21)00701(240)08N53-002 (01)00884999048034(11)210527(21)00702(240)08N53-002 (01)00884999048034(11)210525(21)00703(240)08N53-002 (01)00884999048034(11)210525(21)00704(240)08N53-002 (01)00884999048034(11)210526(21)00705(240)08N53-002 (01)00884999048034(11)210526(21)00706(240)08N53-002 (01)00884999048034(11)210527(21)00707(240)08N53-002 (01)00884999048034(11)210526(21)00708(240)08N53-002 (01)00884999048034(11)210527(21)00709(240)08N53-002 (01)00884999048034(11)210528(21)00710(240)08N53-002 (01)00884999048034(11)210528(21)00711(240)08N53-002 (01)00884999048034(11)210527(21)00712(240)08N53-002

Quantity recalled74 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0463-2022
FDA event ID: 89169
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Terminated
Recall initiated: 6 Dec 2021
FDA classified: 6 Jan 2022
Reported: 12 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Dec 2021	Recall initiated by company
6 Jan 2022	Classified by FDA	+31 days
12 Jan 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is an issue with the installation of updated camera firmware on the system.

Product as listed by the FDA

Alinity m System, Part No. 08N53-002

Where it was distributed

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, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam

California District of Columbia Georgia Illinois Kentucky Maryland Michigan Minnesota Mississippi New Hampshire New Jersey New York Rhode Island South Dakota Texas Wisconsin

Questions about this recall

Why was it recalled?

There is an issue with the installation of updated camera firmware on the system.

Which lots are affected?

Alinity m System, Model 08N53-002 74 impacted serial numbers: 00048, 00076, 00080, 00091, 00105, 00111, 00154, 00155, 00165, 00189, 00191, 00207, 00231, 00232, 00233, 00239, 00252, 00254, 00267, 00280, 00284, 00285, 00288, 00290, 00292, 00293, 00294, 00296, 00302, 00320, 00331, 00343, 00345, 00348, 00357, 00376, 00416, 00418, 00430, 00437, 00466, 00474, 00485, 00486, 00495, 00537, 00540, 00541, 00554, 00566, 00598, 00624, 00629, 00641, 00652, 00656, 00673, 00696, 00697, 00698, 00699, 00700, 00701, 00702, 00703, 00704, 00705, 00706, 00707, 00708, 00709, 00710, 00711, 00712 Impacted UDI numbers: (01)00884999048034(11)190115(21)00048(240)08N53-002 (01)00884999048034(11)190326(21)00076(240)08N53-002 (01)00884999048034(11)190331(21)00080(240)08N53-002 (01)00884999048034(11)190423(21)00091(240)08N53-002 (01)00884999048034(11)190523(21)00105(240)08N53-002 (01)00884999048034(11)190522(21)00111(240)08N53-002 (01)00884999048034(11)190807(21)00154(240)08N53-002 (01)00884999048034(11)190809(21)00155(240)08N53-002 (01)00884999048034(11)190822(21)00165(240)08N53-002 (01)00884999048034(11)191001(21)00189(240)08N53-002 (01)00884999048034(11)191003(21)00191(240)08N53-002 (01)00884999048034(11)191105(21)00207(240)08N53-002 (01)00884999048034(11)200107(21)00231(240)08N53-002 (01)00884999048034(11)200113(21)00232(240)08N53-002 (01)00884999048034(11)200123(21)00233(240)08N53-002 (01)00884999048034(11)200130(21)00239(240)08N53-002 (01)00884999048034(11)200220(21)00252(240)08N53-002 (01)00884999048034(11)200225(21)00254(240)08N53-002 (01)00884999048034(11)200324(21)00267(240)08N53-002 (01)00884999048034(11)200430(21)00280(240)08N53-002 (01)00884999048034(11)200506(21)00284(240)08N53-002 (01)00884999048034(11)200528(21)00285(240)08N53-002 (01)00884999048034(11)200611(21)00288(240)08N53-002 (01)00884999048034(11)200611(21)00290(240)08N53-002 (01)00884999048034(11)200611(21)00292(240)08N53-002 (01)00884999048034(11)200611(21)00293(240)08N53-002 (01)00884999048034(11)200611(21)00294(240)08N53-002 (01)00884999048034(11)200619(21)00296(240)08N53-002 (01)00884999048034(11)200704(21)00302(240)08N53-002 (01)00884999048034(11)200728(21)00320(240)08N53-002 (01)00884999048034(11)200812(21)00331(240)08N53-002 (01)00884999048034(11)200824(21)00343(240)08N53-002 (01)00884999048034(11)200826(21)00345(240)08N53-002 (01)00884999048034(11)200831(21)00348(240)08N53-002 (01)00884999048034(11)200909(21)00357(240)08N53-002 (01)00884999048034(11)200921(21)00376(240)08N53-002 (01)00884999048034(11)201025(21)00416(240)08N53-002 (01)00884999048034(11)201027(21)00418(240)08N53-002 (01)00884999048034(11)201101(21)00430(240)08N53-002 (01)00884999048034(11)201111(21)00437(240)08N53-002 (01)00884999048034(11)201203(21)00466(240)08N53-002 (01)00884999048034(11)201209(21)00474(240)08N53-002 (01)00884999048034(11)201214(21)00485(240)08N53-002 (01)00884999048034(11)201216(21)00486(240)08N53-002 (01)00884999048034(11)201222(21)00495(240)08N53-002 (01)00884999048034(11)210125(21)00537(240)08N53-002 (01)00884999048034(11)210128(21)00540(240)08N53-002 (01)00884999048034(11)210128(21)00541(240)08N53-002 (01)00884999048034(11)210208(21)00554(240)08N53-002 (01)00884999048034(11)210217(21)00566(240)08N53-002 (01)00884999048034(11)210307(21)00598(240)08N53-002 (01)00884999048034(11)210324(21)00624(240)08N53-002 (01)00884999048034(11)210326(21)00629(240)08N53-002 (01)00884999048034(11)210331(21)00641(240)08N53-002 (01)00884999048034(11)210413(21)00652(240)08N53-002 (01)00884999048034(11)210415(21)00656(240)08N53-002 (01)00884999048034(11)210428(21)00673(240)08N53-002 (01)00884999048034(11)210521(21)00696(240)08N53-002 (01)00884999048034(11)210521(21)00697(240)08N53-002 (01)00884999048034(11)210524(21)00698(240)08N53-002 (01)00884999048034(11)210521(21)00699(240)08N53-002 (01)00884999048034(11)210527(21)00700(240)08N53-002 (01)00884999048034(11)210527(21)00701(240)08N53-002 (01)00884999048034(11)210527(21)00702(240)08N53-002 (01)00884999048034(11)210525(21)00703(240)08N53-002 (01)00884999048034(11)210525(21)00704(240)08N53-002 (01)00884999048034(11)210526(21)00705(240)08N53-002 (01)00884999048034(11)210526(21)00706(240)08N53-002 (01)00884999048034(11)210527(21)00707(240)08N53-002 (01)00884999048034(11)210526(21)00708(240)08N53-002 (01)00884999048034(11)210527(21)00709(240)08N53-002 (01)00884999048034(11)210528(21)00710(240)08N53-002 (01)00884999048034(11)210528(21)00711(240)08N53-002 (01)00884999048034(11)210527(21)00712(240)08N53-002

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Abbott Molecular

All 36

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled	Abbott Molecular	Other	Nationwide
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled	Abbott Molecular	Other	Nationwide
30 Apr 2025Device	CLASS II	The Alinity m System is designed to automate the steps recalled	Abbott Molecular	Other	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide