Z-0268-2023Class II

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

Name: Z-0268-2023 Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Creator: Abbott Molecular, Inc.
Published: 2022-10-12
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-10-12 / Open, Classified / root cause: labeling and UDI

FDA source

Abbott Molecular, Inc. began a recall of Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use on 2022-10-12. FDA classified it as Class II and gives the reason as "Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0268-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-12
Posted: 2022-11-18
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Abbott issued a Filed Correction Recall/Urgent Field Safety Notice to its consignees on October 17, 2022 by FedEx priority overnight express. The letter explained the issues, the potential hazards, and the available actions until mandatory upgrade is completed: 1. In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. Available action: This occurrence was only found in-house under non-standard operating conditions. Prior to instrument use, empty waste container. If waste overflow occurs, please follow internal bio- hazardous waste cleaning procedures. 2. Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. Available action: To help mitigate potential occurrence, the following can be done: 1) Verify that only ONE lot of sample prep kit material is on the system at a time. 2) Load one sample prep drawer at a time. Once the first drawer is scanned, verify the scanned information is correct on the SCC. After drawer 1 information has been verified to be correct, load the second drawer. After scanning, verify the correct information for drawer 2 is correct on the SCC. 3. Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. Available action: Take the module out of service per M&D 2752 or clean out the amp detect RVs via M&D 1401, Contact your Abbott representative for further guidance. 4. 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 sepa
Quantity in commerce: 883 units
Distribution: Worldwide distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0268-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0268-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18

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)