Abbott recalls Alinity m System software version 1.6.5 for potential test errors. Affected units may have waste chute issues, barcode misreads, or calibration problems. Contact Abbott for details.
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.
Abbott is recalling the Alinity m System software version 1.6.5 due to potential performance issues that could cause test errors. This affects laboratory equipment used for in vitro diagnostics, where improper handling might lead to incorrect test results.
The software issues include a waste chute flapper that may stay closed, barcode misreads during sample prep, and potential calibration errors from using multiple calibrator lots. These problems could lead to incorrect test results if not addressed.
Laboratories using the Alinity m System for in vitro diagnostics are affected. Users most at risk are those who rely on the system for critical testing where errors could impact results.
The recalled product is the Alinity m System software version 1.6.5 with serial numbers. It was sold for in vitro diagnostic use by Abbott Molecular, Inc.
Verify the software version on your Alinity m System. If it is 1.6.5, it is affected.
The software version 1.6.5 of the Alinity m System is being recalled.
Check if your Alinity m System has software version 1.6.5. The recall affects all units with this software version.
Contact Abbott for details on the remedy. The official recall record does not specify a remedy.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0268-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0268-2023 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
