Z-0462-2022Class II

Alinity m System, Part No. 08N53-002

Name: Z-0462-2022 Alinity m System, Part No. 08N53-002
Creator: Abbott Molecular, Inc.
Published: 2021-12-06
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2021-12-06 / Open, Classified / root cause: software

FDA source

Abbott Molecular, Inc. began a recall of Alinity m System, Part No. 08N53-002 on 2021-12-06. FDA classified it as Class II and gives the reason as "There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0462-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-06
Posted: 2022-01-06
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m System, Part No. 08N53-002
Product code: MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Reason for recall: There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Root cause tag: software
FDA root cause: Software design
Action: On December 06, 2021 Abbott Molecular issued a Product Recall letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative adjusts the amplification detection clamp height on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
Quantity in commerce: 742 devices
Distribution: Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam
Product codes and lots: Alinity m System, Model 08N53-002, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0462-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0462-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-12	2022-01-06

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)