Reported May 22, 2024 · Ongoing
VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine…
Quidelortho
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QUIDELORTHO · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin)
- Product Code131 5589
- Lot codes and dates
- UDI-DI10758750008797
- Lot Numbers3042
- Expiry
09-Apr-20243052
- Expiry
02-May-20243061
- Expiry
06-Jun-20243080
- Expiry
02-May-20243090
- Expiry
14-Jun-20243100
- Expiry
29-Jul-20243110
- Expiry
13-Aug-20243126
- Expiry04-Sep-2024
- Amount recalled
- 21268 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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