Alinity m System, Part No. 08N53-002
FDA Device Recall #Z-0463-2022 — Class II — December 6, 2021
Recall Summary
| Recall Number | Z-0463-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 6, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Molecular, Inc. |
| Location | Des Plaines, IL |
| Product Type | Devices |
| Quantity | 74 devices |
Product Description
Alinity m System, Part No. 08N53-002
Reason for Recall
There is an issue with the installation of updated camera firmware on the system.
Distribution Pattern
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
Lot / Code Information
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
Other Recalls from Abbott Molecular, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1749-2025 | Class II | Alinity m Resp-4-Plex AMP Kit, List Number 09N7... | Apr 28, 2025 |
| Z-1748-2025 | Class II | Alinity m Resp-4-Plex Amplification (AMP) Kit (... | Apr 28, 2025 |
| Z-1665-2025 | Class II | The Alinity m System is designed to automate th... | Mar 20, 2025 |
| Z-0233-2025 | Class II | Abbott Alinity m HPV AMP Kit, used with the Ali... | Sep 12, 2024 |
| Z-0234-2025 | Class II | Abbott Alinity m STI AMP Kit, used with the Ali... | Sep 12, 2024 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.