QUIDELORTHO's Free T3 Reagent Packs (Lot 3042-3126) may produce biased thyroid test results, potentially affecting patient care. Affected units include specific lot numbers with expiry dates through July 2024.
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
QUIDELORTHO is recalling Free T3 Reagent Packs that, when used with Free T3 Calibrators, can give inaccurate thyroid test results. This may lead to incorrect patient diagnoses or delayed treatment decisions.
The reagent packs may produce results that are too high (positively biased) when used with Free T3 Calibrators. This can cause incorrect thyroid test outcomes, potentially leading to wrong treatment decisions or delays in patient care.
Healthcare providers using the VITROS Free T3 Reagent Packs with Free T3 Calibrators are most at risk. Patients receiving thyroid tests using these packs could experience inaccurate results.
Check the product code 131 5589 and lot numbers 3042 through 3126 on the reagent pack. These units were sold with expiry dates from April 2024 through September 2024.
Look for product code 131 5589 and lot numbers 3042 to 3126 on the reagent pack.
The reagent packs may produce results that are too high when used with Free T3 Calibrators, potentially causing inaccurate thyroid test results and delaying patient care.
Lot numbers 3042 through 3126, with expiry dates from April 2024 through September 2024.
The recall does not require immediate stoppage; affected units should be checked and replaced if necessary.
We’ve drafted a message you can send QUIDELORTHO to request your refund or repair — edit it as you like.
Subject: Recall Z-1818-2024 — QUIDELORTHO QUIDELORTHO Hello, I own a QUIDELORTHO that is covered by recall Z-1818-2024 from QUIDELORTHO. 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.
