Recall Z-0844-2019— Ortho Clinical Diagnostics Inc

Name: FDA recall Z-0844-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-29

Class II · Terminated

Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2018-11-29, terminated 2024-02-06. It names one FDA 510(k) clearance: K033300. Product: Vitros Myoglobin Calibrators, Product Code 6801043 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 myoglobin in human serum and plasma. Reason: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration..

Recalling firm: Ortho Clinical Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2018-11-29
Terminated: 2024-02-06
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.·cleared 2003-11-05

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 Myoglobin Calibrators, Product Code 6801043 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 myoglobin in human serum and plasma

Reason for recall

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

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