Abbott recalls Alinity i Processing Modules with specific part numbers due to foaming and dried residue in the buffer reservoir, which may affect test accuracy. Affected units include serial numbers Ai01001-Ai01455, Ai01457, Ai01459.
Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed.
Abbott is recalling Alinity i Processing Modules with specific part numbers because improper pump calibration causes foaming and dried residue in the buffer reservoir. This could lead to inaccurate test results if the device is used without correction.
The pump assembly calibration issue causes excessive foaming and dried buffer residue in the reservoir. This can lead to inaccurate test results if the device is used without correction.
Users of the Alinity i Processing Module for laboratory testing are affected. Those with the specific serial numbers or part numbers listed are most at risk.
Check the serial numbers on the device: Ai01001 to Ai01455, Ai01457, or Ai01459. Also, verify the part numbers: 03R65-01, A-30108552-01, or A-30109694-01.
Look for serial numbers Ai01001 to Ai01455, Ai01457, or Ai01459 on the Alinity i Processing Module.
Part numbers 03R65-01, A-30108552-01, and A-30109694-01 are affected.
Check the serial numbers: Ai01001 to Ai01455, Ai01457, or Ai01459. Also, verify the part numbers listed in the recall notice.
Improper pump calibration causes foaming and dried buffer residue in the reservoir, which may lead to inaccurate test results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0789-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0789-2019 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.
