Reported Jan 20, 2021 · Terminated
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and…
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- 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 assayscobas¿ 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
- Lot codes and dates
- All units UDI04015630929016
- Amount recalled
- 597 units US; 3411 units OUS
Where it was sold
- Nationwide
Why it was recalled
Dirty Lens May Cause Invalid or False Positive Results
This product could cause temporary or reversible health problems — stop using it.
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