Abbott recalls Alinity i Estradiol Reagent Kit (List 07P5020) 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 Estradiol Reagent Kit (List Number 07P5020) because some cartridges may have damaged bottle necks that could cause reagent loading failures on the Alinity i instrument. This issue affects users who have the specific lot numbers listed in the recall notice.
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, but does not pose a direct safety risk to users.
Users of the Alinity i Estradiol Reagent Kit with the specific lot numbers listed in the recall notice are most at risk. This typically includes laboratory professionals using the Alinity i instrument for estradiol testing.
Check the product label for the lot numbers listed in Appendix A of the recall notice. The Alinity i Estradiol Reagent Kit has List Number 07P5020 and specific UDI/Lot Numbers starting with (01)00380740131159 or (17)190317(10) 90193UI00.
Look for the lot numbers listed in Appendix A of the recall notice to confirm if your kit is affected.
The Alinity i Estradiol Reagent Kit with List Number 07P5020 is being recalled.
Damaged bottle necks may cause reagent loading failures on the Alinity i instrument, potentially leading to inaccurate test results.
No immediate stop is required; check the lot numbers to see if your kit is affected before taking action.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0667-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0667-2019 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.
