Medical device manufacturer, Roche, has issued a medical device safety alert concerning its cobas z 480 analyzer (GMMI: 05200881001, Device Identifier: 04015630929016).
The affected full workflow assays include:
And the affected PCR only workflow assays include:
The manufacturer received 15 complaint cases alleging false positive or invalid results with select cobas 4800 IVD assays. Their complaint investigations confirmed the presence of dirty lenses within the cobas z 480 analyzer in 10 of the 15 escalated cases. After lens cleaning by manufacturer's Field Service Engineers, no additional false positive results were observed. The false positive results were attributed to spatial cross-talk, due to a dirty lens, where the fluorescent signal from true positive wells scattered to adjacent wells. The manufacturer confirmed that improper sealing of the AD-plate contributes to dirty lenses. Although dirty lenses were observed in these studies, spatial cross-talk and false positive/invalid results were not reproduced. These observations suggest that dirty lenses due to improper sealing of the AD-plate alone do not cause spatial cross-talk and false positive results. There are likely additional factors, including age and usage of the instrument as well as laboratory environmental conditions that contribute to dirty lenses, spatial cross-talk and false positive/invalid results.
According to manufacturer, the probability of serious adverse health effects due to a false positive or invalid/delayed result from their Infectious Disease assays is extremely unlikely (i.e., not likely). Also, for Genomics and Oncology assays, the probability of serious adverse health consequences to the population at greatest risk and to the overall population from an invalid/delayed result is extremely unlikely (i.e., not likely).
The local supplier will schedule site visits to inspect the optical lens for Full Workflow Customers running Virology, HPV, CT/NG, C. Diff. assays in the cobas z 480 analyzer detection unit and clean, if necessary. Additionally, updated inspection instructions will be included in the periodic maintenance schedule within the service documentation and will be performed yearly. And for PCR Only Workflow Customers Running EGFR, BRAF, and KRAS assays, the local supplier will request problem reports for review, and schedule cleaning visits, if necessary. The manufacturer is in the process of developing a service tool that will utilize customer raw data files generated with the referenced PCR only workflow IVD assays to determine whether cobas z 480 analyzer lens cleaning is required or not. It is important to note that the User Assistance provides detailed instructions on how to properly seal AD-plates before amplification/detection in the cobas z 480 analyzer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 25 November 2020