Roche Molecular Systems, Inc. recalls The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detectio…

Recall date

November 19, 2020

Source

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

Recall number

Z-0846-2021

FDA classification

Class II

Brand / firm

Roche Molecular Systems, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands, Switzerland, Czech Republic, Romania, Sweden, Norway, Denmark, Hungary, Ireland, Slovakia, Croatia, Bulgar…

Why it was recalled

Dirty Lens May Cause Invalid or False Positive Results

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: cobas¿ 4800 BRAF V600 Mutation Test cobas¿ Cdiff Test for use on the cobas¿ 4800 System cobas¿ CT/NG v2.0 Test cobas¿ EGFR Mutation Test v2 cobas¿ Factor II and Factor V Test cobas¿ 4800 HPV Test cobas¿ HSV 1 and 2 Test for use on the cobas¿ 4800 System cobas¿ KRAS Mutation Test cobas¿ MRSA/SA Test for use on the cobas¿ 4800 System