Abbott recalls Alinity i Ferritin Reagent Kit (List 07P6530) due to potential bottle neck damage causing reagent loading failures. Affected units include specific lot numbers from Appendix A.
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 Ferritin Reagent Kit (List Number 07P6530) because some reagent cartridges may have damaged bottle necks that can cause the reagent to fail during loading on the Alinity i instrument. This could lead to inaccurate test results if the reagent doesn't load properly.
Damaged bottle necks in the reagent cartridges can cause the reagent to fail during the loading process on the Alinity i instrument. This may result in inaccurate test results if the reagent doesn't load properly.
Users of the Alinity i Ferritin Reagent Kit (List Number 07P6530) with specific lot numbers from Appendix A are affected. Laboratory personnel who use this reagent kit for ferritin testing are most at risk.
Check the lot numbers on the reagent kit packaging: (01)00380740131487 (17)190730(10)91532UI00/91532UI00 or (01)00380740131487 (17)190905(10)93238UI00/93238UI00. The product is sold by Abbott Ireland Diagnostics Division.
Verify the lot numbers on the reagent kit packaging to determine if it is affected.
Abbott has identified a manufacturing issue that can cause damage to the bottle neck in some reagent cartridges, which may lead to failure during the reagent loading process on the Alinity i instrument.
Check the lot numbers on the reagent kit packaging to see if it is affected. If it is, contact Abbott for further instructions.
The recall record does not specify a remedy or fix 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-2208-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2208-2019 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.
