Clinical Diagnostic Systems Recalls VITROS TSH Reagent Packs Due to Calibration Issues
Clinical Diagnostic Systems is recalling specific lots of VITROS TSH Reagent Packs because they may generate higher-than-expected calibrator signals, potentially causing calibration curves to fall outside quality parameters.
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 agency classification is Class III, which by definition is unlikely to cause adverse health consequences. The issue is a technical calibration deviation without reported injuries or illnesses.
Plain-English summary
Clinical Diagnostic Systems is recalling specific lots of VITROS Immunodiagnostic Products TSH Reagent Packs. The affected lots are #5470, #5430, and #5178. Lot #5430 was not distributed in the United States, and Lot #5178 expired on March 31, 2017, so no action was taken on that lot.
The recall was initiated because the reagent lots were found to generate higher than expected Calibrator level 2 signals on some customer systems. These responses cause a higher than expected frequency of customer-generated calibration curves to fall outside of the calibration quality parameter measuring the gradient between Calibrator Level 2 and Calibrator Level 3.
Distributors were notified via letter. The source text does not specify instructions for end-users or consumers, as the product is a medical device reagent used in diagnostic systems.
The recalled product
- Product
- VITROS Immunodiagnostic Products TSH Reagent Pack
- Manufacturer
- Clinical Diagnostic Systems
- Hazard
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 (3)
- Lot 5470
- expiry date: 24-May-2018 Lot 5430
- expired on 31-Mar-2017
Distribution
Distribution scope not specified by the agency.
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