Recall Z-0313-2017— Ortho-Clinical Diagnostics

Name: FDA recall Z-0313-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-22

Class III · Terminated

Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2016-06-22, terminated 2018-06-11. It names one FDA 510(k) clearance: K030067. Product: VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.. Reason: The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2016-06-22
Terminated: 2018-06-11
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSOrtho-Clinical Diagnostics·cleared 2003-01-17

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 HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.

Reason for recall

The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.

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