Recall Z-1337-2013— Ortho-Clinical Diagnostics

Name: FDA recall Z-1337-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-03

Class III · Terminated

Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-04-03, terminated 2017-03-02. It names one FDA 510(k) clearance: K973030. Product: VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).. Reason: Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2013-04-03
Terminated: 2017-03-02
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K973030 — VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)Johnson & Johnson Clinical Diagnostics, Inc.·cleared 1997-09-04

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 CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).

Reason for recall

Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.

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