Abbott recalls Alinity i 25-O:OH Vitamin D Reagent Kits with potential bottle neck damage causing reagent loading failures. Affected units include specific UDI/Lot numbers 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 certain Alinity i 25-OH Vitamin D Reagent Kits due to a manufacturing issue that can damage the bottle neck in some reagent cartridges. This damage may cause the reagent to fail during the loading process on the Alinity i instrument.
A manufacturing issue can cause damage to the bottle neck of some reagent cartridges. If the bottle neck is damaged, it may lead to a failure during the reagent loading process on the Alinity i instrument.
Users of the Alinity i 25-OH Vitamin D Reagent Kit with specific UDI/Lot numbers listed in the recall notice are affected. Laboratory personnel using these kits are most at risk.
Check the UDI/Lot numbers on the reagent kit packaging. Affected units include specific UDI/Lot numbers listed in the recall notice: (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 and (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00.
Verify the UDI/Lot numbers on the reagent kit packaging against the list provided in the recall notice.
A manufacturing issue can cause damage to the bottle neck of some reagent cartridges, which may lead to failure during the reagent loading process on the Alinity i instrument.
Check the UDI/Lot numbers on the packaging. Affected units include specific UDI/Lot numbers listed in the recall notice: (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 and (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00.
The recall notice does not specify a remedy, so check the official recall notice for further instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0669-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0669-2019 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.
