Alinity m recallZ-0463-2022 · Abbott Molecular, Inc. · initiated Dec 6, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Molecular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is an issue with the installation of updated camera firmware on the system.
FDA root cause category: Software design
What the company is doing
On December 06, 2021 Abbott Molecular issued a Product Correction letter to all customers who received an Alinity m instrument impacted by this issue (List Number 08N53 002). Customers are being informed of a previously completed assessment conducted by Abbott FSEs. Customers were initially informed at the time of the assessment, but proper reconciliation of the communication was not performed. 100% of customers are requested to return to Abbott a Customer Reply Form acknowledging receipt and understanding, and/or a request for assistance. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
Recall details
- Recall number
- Z-0463-2022
- Status
- Terminated
- Initiated by the company
- Dec 6, 2021
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 74 devices
- Product code
- MZP
- FDA submissions
- P190025
- 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, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam
Product description
Alinity m System, Part No. 08N53-002
Code information (models, lots, serial numbers)
Show the full code information (4k characters)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity m 08N53-002Abbott Molecular Inc. · real time Nucleic acid amplification system4 recalls950 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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