Z-1518-2022Class II

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Name: Z-1518-2022 The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Creator: Abbott Molecular, Inc.
Published: 2022-07-19
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-07-19 / Completed / root cause: manufacturing process

FDA source

Abbott Molecular, Inc. began a recall of The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use on 2022-07-19. FDA classified it as Class II and gives the reason as "Incorrect optical calibration". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1518-2022
Classification: Class II
Status: Completed
Initiated: 2022-07-19
Posted: 2022-08-12
Recalling firm: Abbott Molecular, Inc.
Product: The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Product code: MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Reason for recall: Incorrect optical calibration
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The 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 commerce: 1
Distribution: There was only foreign distribution to Italy.
Product codes and lots: Serial Number 00654

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1518-2022	Class II	Completed	Voluntary: Firm initiated	2022-08-24	2022-08-12

Product code MZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)