Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
VITROS Immunodiagnostic Products TSH Reagent Pack Recalled by Clinical Diagnostic Systems Due to VITROS TSH reagent lots have been found to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Clinical Diagnostic Systems directly.
Affected Products
VITROS Immunodiagnostic Products TSH Reagent Pack
Quantity: Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)
Why Was This 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.
Where Was This Sold?
Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
About Clinical Diagnostic Systems
Clinical Diagnostic Systems has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report