Recall Z-0846-2021 ยท MAQ Kit, Dna Detection, Human Papillomavirus
Roche Molecular Systems, Inc.
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
| Date | Nov 19, 2020 |
| Status | Terminated |
| Reason | Dirty Lens May Cause Invalid or False Positive Results |
| Root cause | Device Design |
| Action | Roche issued Urgent Medical Device Correction on 11/19/20 via UPS Ground (receipt required). Letter states reason for recall, health risk and action to take: Inform any operators that use the cobas z 480 analyzer of the potential hazards associated with this issue and provide a copy of this notification, as appropriate. " Ensure the AD-plates are sealed properly before performing amplification/detection on your cobas z 480 analyzer(s). " Refer to the cobas 4800 System User Assistance/cobas 4800 System Operators Manual in the section To seal the microwell plate for detailed instructions on ho |
| Quantity | 597 units US; 3411 units OUS |
| 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, Bulgari |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.