QUIDELORTHO Free T3 Calibrators used with T3 Reagent Packs may produce biased results, potentially causing incorrect patient outcomes. Affected units include specific lot numbers and expiry dates listed in the recall notice.
Free T3 Calibrators used with T3 Reagent Packs 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 recalls Free T3 Calibrators that, when used with T3 Reagent Packs, can produce inaccurate test results. This may lead to incorrect patient diagnoses or delays in treatment. Affected units have specific lot numbers and expiry dates.
The Free T3 Calibrators used with T3 Reagent Packs can produce positively biased results. This means test results may be too high, leading to incorrect patient diagnoses or delayed treatment decisions.
Users of thyroid function tests who have the specific lot numbers and expiry dates listed in the recall notice are most at risk. This includes healthcare professionals and labs using the VITROS system.
Check for product code 111 2820 and lot numbers 3042 through 3126 with specific expiry dates listed in the recall notice. The product is for use with Free T3 Reagent Packs in the VITROS system.
Verify the product code (111 2820) and lot numbers (3042-3126) with expiry dates listed in the recall notice.
The Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results, causing inaccurate patient test results or delays in treatment.
Lot numbers 3042 through 3126 with specific expiry dates listed in the recall notice.
No action is required beyond checking the product details. The recall does not specify a stop-use instruction.
We’ve drafted a message you can send QUIDELORTHO to request your refund or repair — edit it as you like.
Subject: Recall Z-1819-2024 — QUIDELORTHO QUIDELORTHO Hello, I own a QUIDELORTHO that is covered by recall Z-1819-2024 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.
