Abbott recalls Alinity i TSH Reagent Kit (List 07P4830) due to potential bottle neck damage in cartridges that may cause reagent loading failure. Affected units include specific UDI/Lot numbers listed in 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 TSH Reagent Kit (List Number 07P4830) because some cartridges may have damaged bottle necks that could cause the reagent to fail during loading on the Alinity i instrument. This issue affects specific units with the UDI/Lot numbers listed in Appendix A.
Damaged bottle necks in the reagent cartridges can cause the reagent to fail during the loading process on the Alinity i instrument. This may lead to inaccurate test results if the reagent does not load properly.
Healthcare professionals using the Alinity i TSH Reagent Kit for laboratory testing are most at risk if they have the specific UDI/Lot numbers listed in Appendix A. The recall applies to the Alinity i instrument's reagent cartridges.
Check the UDI/Lot numbers on the reagent kit packaging. Affected units include specific combinations like (01)00380740131159 (17)190710(10)90061UI00 and similar numbers listed in Appendix A.
Look for UDI/Lot numbers on the packaging that match the affected numbers listed in Appendix A.
Abbott has identified a manufacturing issue that can cause bottle neck damage in some reagent cartridges, which may lead to reagent loading failure on the Alinity i instrument.
Check the UDI/Lot numbers on the packaging against the affected numbers listed in Appendix A. If you have the affected numbers, contact Abbott for further instructions.
The recall record does not specify a remedy; affected units should be checked against the listed UDI/Lot numbers.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0664-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0664-2019 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.
