Z-1009-2023Class II

Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which...

Name: Z-1009-2023 Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which...
Creator: Abbott Molecular, Inc.
Published: 2022-12-09
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-12-09 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Molecular, Inc. began a recall of Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection... on 2022-12-09. FDA classified it as Class II and gives the reason as "The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1009-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-09
Posted: 2023-01-20
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On December 09, 2022, Abbott Molecular issued a Field Correction Recall/Urgent Field Safety Notice to all customers who have the Alinity m System by FedEx priority overnight express. The letter explained the problems and provided the following information: "An assessment of your Alinity m System associated with the above listed potential issues will be completed remotely if your system is currently connected to AbbottLink or alternatively via onsite inspection by an Abbott representative. If necessary, an Abbott representative will schedule time to corrected the affected ADU9s) on your Alinity m System(s). In the interim, please continue to follow your laboratory protocols for any suspected incorrect results. Following the assessment and any necessary service, an additional communication will follow. If it is determined that your instrument was impacted, please assess the impact to your laboratory in reviewing previously generated test results. This recall is to be carried out at the user/customer level. If this product has been further distributed by your facility, please notify any additional impacted customers. Please review this information with laboratory personnel and retain this communication for future reference. If you have any questions regarding the communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-553-7042 Option 2."
Quantity in commerce: 918 units
Distribution: x
Product codes and lots: Model Number: 08N53-002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20

Product code OOI

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)