Recall Z-0846-2021— Roche Molecular Systems, Inc.

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2020-11-19, terminated 2023-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Dirty Lens May Cause Invalid or False Positive Results.

Recalling firm

Roche Molecular Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2020-11-19

Terminated

2023-08-10

Firm location

Branchburg, NJ, United States

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