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ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No
Recalled August 24, 2016 · FDA recall Z-2580-2016 · ORTHO-CLINICAL DIAGNOSTICS
Hazard
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH. · FDA Class III
Units
Domestic: 2883, Foreign: 1261
Sold at
Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
Description
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
Product
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) 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.
Manufacturer(s)
ORTHO-CLINICAL DIAGNOSTICS
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →