| | Class 2 Device Recall Alinity M System |  |
| Date Initiated by Firm | December 06, 2021 |
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| Create Date | January 06, 2022 |
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| Recall Status1 |
Terminated 3 on September 30, 2024 |
| Recall Number | Z-0463-2022 |
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| Recall Event ID |
89169 |
| PMA Number | P190025 |
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| Product Classification |
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus - Product Code MZP
|
| Product | Alinity m System, Part No. 08N53-002 |
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| 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
|
| FEI Number |
3005248192
|
Recalling Firm/
Manufacturer |
Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
|
| For Additional Information Contact | Ray Bastian
224-361-7619 |
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Manufacturer Reason
for Recall | There is an issue with the installation of updated camera firmware on the system. |
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FDA Determined
Cause 2 | Software design |
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| Action | 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. |
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| Quantity in Commerce | 74 devices |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| PMA Database | PMAs with Product Code = MZP
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