Reported May 28, 2014 · Terminated
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or…
Ortho-Clinical Diagnostics
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: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
- Lot codes and dates
- Catalog Number139 3396
- Lot Number1590
- Amount recalled
- 583 units Total (357 units domestically & 226 units internationally)
Where it was sold
- Nationwide
Why it was recalled
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
This product could cause temporary or reversible health problems — stop using it.
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