Ortho Clinical Diagnostics recalls VITROS TT4 Reagent Packs with Product Code 8744468 due to increased unsuccessful calibrations. Affected units may need replacement to ensure accurate test results.
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs with Product Code 8744468 because they sometimes fail to calibrate properly. This could lead to inaccurate test results if the reagent is used without proper calibration.
The reagent packs may fail to calibrate correctly, which can result in inaccurate test results. This could affect the reliability of diagnostic tests, but does not pose a direct physical risk to users.
Users of VITROS TT4 Reagent Packs with Product Code 8744468 are likely affected. Laboratory staff and healthcare providers who use these reagents for testing are at the highest risk.
Check for Product Code 8744468 on the reagent pack. The Lot Number 2340 and Unique Device Identifier (UDI) 10758750005147 are also associated with this recall.
Look for Product Code 8744468, Lot Number 2340, and UDI 10758750005147 on the reagent pack.
The reagent packs exhibit an increase in the frequency of unsuccessful calibrations, which could lead to inaccurate test results.
Check for Product Code 8744468, Lot Number 2340, and UDI 10758750005147 on the reagent pack.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for guidance.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1834-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-1834-2020 from Ortho Clinical Diagnostics. 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.
