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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity m System

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 Class 2 Device Recall Alinity m Systemsee related information
Date Initiated by FirmJuly 19, 2022
Create DateAugust 12, 2022
Recall Status1 Completed
Recall NumberZ-1518-2022
Recall Event ID 90651
PMA NumberP190025 
Product Classification Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus - Product Code MZP
ProductThe Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Code Information Serial Number 00654
FEI Number 3005248192
Recalling Firm/
Manufacturer		 Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information ContactRaymond Bastian
224-361-7000
Manufacturer Reason
for Recall		Incorrect optical calibration
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm issued a letter dated 7/19/2022 via Abbott representative delivery on 7/19/2022 confirming the issue the customer had with their instrument. The letter also said the impacted ADU4 module was taken out of service on 1/25/2022 and was then replaced with a new module on 3/22/2022. The letter discussed the potential impact and the necessary actions to take which included completing and returning the Customer Reply Form and reviewing this information with laboratory personnel and retain the communication for future reference.
Quantity in Commerce1
DistributionThere was only foreign distribution to Italy.
Total Product Life CycleTPLC Device Report
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.
PMA DatabasePMAs with Product Code = MZP
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