Z-1349-2023Class II

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4

Name: Z-1349-2023 Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4
Creator: Abbott Molecular, Inc.
Published: 2022-11-11
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-11-11 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Molecular, Inc. began a recall of Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4 on 2022-11-11. FDA classified it as Class II and gives the reason as "The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This...". 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-1349-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-11
Posted: 2023-04-06
Recalling firm: Abbott Molecular, Inc.
Product: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The field service engineer installed the missing plunger assembly in the clamp bar while at the consignee location on 11/11/2022. The recalling firm issued the recall letter on 3/1/2023 via overnight mail to their sole consignee. The letter explains the issue, the potential impact, and the necessary actions, which includes placing the impacted ADU out of service and contacting Abbott technical support regarding concerns about the performance of the instrument or results. The letter is to be reviewed with the Medical Director or Laboratory Management and the consignee is to follow their laboratory protocol regarding the need for review of previously reported patient results using the affected system. A customer reply form is enclosed with the letter to acknowledge receipt and to indicate it was disseminated to all users, understood, and implemented. If you have any questions regarding this communication, please contact your local Abbott representative or call DVP Quality Assurance, at 224-361-7000.
Quantity in commerce: 1
Distribution: US Distribution to state of: PA, a government account.
Product codes and lots: Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1349-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1349-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-06

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)