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
Recall Date: Nov 19, 2020
Roche Molecular Systems, Inc.
Recall ID: 86879
Product ID: 184741
Enforcement Date: Jan 20, 2021
Last Published: Jan 12, 2021
Emert Number: Z-0846-2021
Emert Status: Announced