VITROS Immunodiagnostic Products HBsAg Controls recalled over hepatitis A risk

Recall date

June 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ortho-Clinical Diagnostics recalls VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in moni…

Recall number

Z-0313-2017

FDA classification

Class III

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.