Recall Z-1322-2018— Clinical Diagnostic Systems

Name: FDA recall Z-1322-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-11

Class III · Terminated

Class III FDA medical device recall by Clinical Diagnostic Systems, initiated 2018-01-11, terminated 2020-09-08. It names one FDA 510(k) clearance: K083173. Product: VITROS Immunodiagnostic Products TSH Reagent Pack. Reason: 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..

Recalling firm: Clinical Diagnostic Systems
Classification: Class III
Status: Terminated
Initiated: 2018-01-11
Terminated: 2020-09-08
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K083173 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMOrtho-Clinical Diagnostics·cleared 2008-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITROS Immunodiagnostic Products TSH Reagent Pack

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.