Roche cobas z 480 Analyzer Recalled for Dirty Lens Risk
Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (invalid or false positive diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas z 480 analyzer, a plate-based automated amplification and detection system for nucleic acids. The recall is due to a dirty lens that may cause invalid or false positive results.
The affected units are intended to be used as an in-vitro diagnostic or screening system providing real-time PCR amplification and detection for human samples. The product is used by laboratory professionals trained in laboratory techniques. The recall covers 597 units in the United States and 3,411 units outside the United States.
The recall is classified as Class II by the FDA. Users should contact Roche Molecular Systems, Inc. for further instructions on how to proceed with the affected equipment.
The recalled product
- 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
- Manufacturer
- Roche Molecular Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units UDI: 04015630929016
Distribution
Distributed nationwide across the United States.
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