Abbott recalls Alinity s System software version 2.8.0 (serials AS1001-AS1368) due to wash buffer error causing potential inaccurate test results. This is an in vitro diagnostic device.
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Abbott is recalling Alinity s System software version 2.8.0 for a wash buffer error that uses 1 mL instead of 3 mL of buffer. This could lead to inaccurate test results for in vitro diagnostics.
The software error causes the system to use 1 mL of wash buffer instead of the required 3 mL during the probe wash cycle. This incorrect buffer usage can lead to inaccurate test results for in vitro diagnostic tests.
Users of the Alinity s System (serial numbers AS1001 through AS1368) who perform in vitro diagnostic tests may be affected. Healthcare professionals using this device for lab testing are most at risk.
Check if your Alinity s System has software version 2.8.0, identified by serial numbers AS1001 through AS1368. The device is intended for in vitro diagnostic use only.
Contact Abbott to update to the corrected software version 2.8.1 or later.
No, this recall is for a software error that could lead to inaccurate test results, not a safety hazard.
Contact Abbott to update to the corrected software version 2.8.1 or later.
Check if your Alinity s System has serial numbers AS1001 through AS1368 and software version 2.8.0.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0749-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0749-2022 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.
