Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2580-2016 — 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

U.S. FDA — Device Enforcement · United Kingdom · 2016-07-28 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2580-2016
Date of alert: 2016-07-28
Country / jurisdiction: United Kingdom
Risk level: Class III
Risk type: recall
Brand: ORTHO-CLINICAL DIAGNOSTICS
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10758750000227

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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