Abbott recalls Alinity i Progesterone Reagent Kit (List 08P3620) due to potential bottle neck damage in reagent cartridges that may cause failure during instrument loading. Affected units have specific UDI/lots listed in the recall notice.
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 Progesterone Reagent Kits with certain lot numbers because a manufacturing issue might damage the bottle neck of the reagent cartridges. This could cause the reagent to fail during the loading process on the Alinity i instrument. The issue is specific to certain production batches and does not affect all units.
A manufacturing issue can cause damage to the bottle neck of some reagent cartridges. If the bottle neck is damaged, the reagent may fail to load properly on the Alinity i instrument, potentially leading to inaccurate test results.
Users of the Alinity i Progesterone Reagent Kit with specific UDI/lot numbers listed in the recall notice are affected. Laboratory personnel using the kit are most at risk if the bottle neck damage occurs.
Check the UDI/lot numbers on the reagent kit packaging. Affected units have specific UDI/lots listed in the recall notice: (01)00380740121877 (17)190503(10)91254UI00 / 91254UI00 and (01)00380740121877 (17)190618(10)92360UI00 / 92360UI00.
Compare your kit's UDI/lot numbers with the affected lots listed in the recall notice.
Abbott has identified a manufacturing issue that can damage the bottle neck of some reagent cartridges, which may cause failure during the reagent loading process on the Alinity i instrument.
Check your kit's UDI/lot numbers against the affected lots listed in the recall notice. If it matches, contact Abbott for further instructions.
The recall addresses potential failure during the reagent loading process, but there is no indication of physical injury risk. The hazard is limited to test accuracy.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0668-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0668-2019 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.
