Reported Apr 18, 2018 · Terminated
VITROS Immunodiagnostic Products TSH Reagent Pack
Clinical Diagnostic Systems
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Clinical Diagnostic Systems · 601 Lee Rd Ny · Rochester, NY · 14652-0001
Is this the product you have?
- VITROS Immunodiagnostic Products TSH Reagent Pack
- Lot codes and dates
- Lot 5470
- expiry date24-May-2018 Lot 5430
- expiry date01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017
- Amount recalled
- Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)
Why it was recalled
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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