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 w
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems, Inc. is recalling the cobas z 480 analyzer, a plate-based automated amplification and detection system for nucleic acids used for in vitro diagnostic testing. The recall affects 597 units in the United States and 3,411 units outside the US, distributed across numerous countries including Canada, Germany, Italy, Spain, the United Kingdom, France, Australia, and many others. All recalled units are identified by UDI 04015630929016.
The analyzer is being recalled because a dirty lens may cause invalid or false positive test results. The recall notice does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Dirty Lens May Cause Invalid or False Positive Results
Reason for recall: Dirty Lens May Cause Invalid or False Positive Results Distribution: 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, Bulgaria, Finland, Lithuania, Bosnia-Herz, Slovenia, Iceland, Estonia, Australia, Cambodia, China, Hong Kon Quantity: 597 units US; 3411 units OUS Lot/code info: All units UDI: 04015630929016
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.