Abbott recalls Alinity i Free T4 Reagent Kit (List 07P703: 0100380740121822) due to potential bottle neck damage causing reagent loading failures. Affected units may need replacement.
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 Free T4 Reagent Kits with specific lot numbers because a manufacturing issue could damage the bottle neck, leading to reagent loading failures on the Alinity i instrument. This affects laboratory users who rely on these kits for thyroid hormone testing.
A manufacturing defect can cause the bottle neck of the reagent cartridge to be damaged. If damaged, the cartridge may fail during the reagent loading process on the Alinity i instrument, leading to inaccurate test results.
Laboratory users who purchased the Alinity i Free T4 Reagent Kit with the listed lot numbers are most at risk. The hazard is specific to the reagent cartridges and does not affect the instrument itself.
Check the lot numbers on the reagent kit packaging: (01)00380740121822 or (01)00380740121822 (17)190727(10)90111UI00 / 90111UI00 and (01)00380740121822 (17)190911(10)92388UI00 / 92388UI00. The kits were sold by Abbott Ireland Diagnostics Division.
Verify the lot numbers on the reagent kit packaging to see if they match the affected numbers listed in the recall.
A manufacturing issue can cause damage to the bottle neck of the reagent cartridge, which may lead to failure during the reagent loading process on the Alinity i instrument.
No, the recall does not require immediate stop use. Affected units may need replacement if the bottle neck is damaged.
Check the lot numbers on the packaging: (01)00380740121822 or (01)00380740121822 (17)190727(10)90111UI00 / 90111UI00 and (01)00380740121822 (17)190911(10)92388UI00 / 92388UI00.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0665-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0665-2019 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.
