Alinity m System, Part No. 08N53-002
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- December 6, 2021
- Terminated
- September 30, 2024
- Recall Number
- Z-0463-2022
- Quantity
- 74 devices
- Firm Location
- 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, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.