Ortho-Clinical Diagnostics Recalls VITROS TSH Reagent Packs Due to Calibration Failures
Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a delay in testing results due to calibration failures, not a direct physical injury or misdiagnosis.
Plain-English summary
Ortho-Clinical Diagnostics has issued a field correction for VITROS Immunodiagnostic Products TSH Reagent Packs, specifically Lot 5040. The recall was initiated because the reagent lot exhibited a higher-than-expected frequency of customer calibration curves falling outside of the required calibration quality parameters. As a result, the affected reagent packs are considered unusable for processing samples.
The issue may cause an unexpected increase in unsuccessful calibrations for customers using this specific lot. This can lead to delays in testing and reporting results for thyroid stimulating hormone (TSH) measurements. The affected product is used for the in vitro quantitative measurement of TSH in human serum and plasma to aid in the differential diagnosis of thyroid disease.
The recall covers 2,883 units distributed domestically in the United States and 1,261 units distributed internationally. Domestic distribution included shipments to Virginia, West Virginia, Georgia, Tennessee, Kentucky, Minnesota, South Dakota, Arkansas, and Oklahoma. International distribution included Canada. The affected lot has an expiry date of December 19, 2016. Users should stop using the affected reagent packs and contact the manufacturer for further instructions.
The recalled product
- 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
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 5040 (Expiry date 19 Dec 2016)
Distribution
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