Abbott recalls Alinity i Total Beta-hCG Reagent Kit (List 07P5121) due to potential bottle neck damage in some cartridges, which may cause reagent loading failures on the Alinity i instrument.
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Abbott is recalling Alinity i Total Beta-hCG Reagent Kit (List Number 07P5121) because some cartridges may have damaged bottle necks that could cause reagent loading failures on the Alinity i instrument. This issue affects laboratory users who use the kit for pregnancy testing.
Damaged bottle necks in some reagent cartridges can cause the reagent to fail during the loading process on the Alinity i instrument. This may lead to inaccurate test results or instrument errors.
Laboratory users who own or use the Alinity i Total Beta-hCG Reagent Kit (List Number 07P5121) are most at risk. The recall affects specific lots of cartridges sold with the kit.
Check for the product name 'Alinity i Total Beta-hCG Reagent Kit' with List Number 07P5121. Look for UDI/Lot Numbers starting with (01)00380740160616 or (17)190807(10)92056UI00.
Verify the UDI/Lot Numbers on the kit to confirm if it's in the recalled range.
Abbott has identified a manufacturing issue that can cause damage to the bottle neck in some reagent cartridges, which may lead to reagent loading failures on the Alinity i instrument.
Check the UDI/Lot Numbers on the kit to see if it's in the recalled range. If it is, contact Abbott for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0666-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0666-2019 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.
