Device product
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Z-2344-2018
Product summary
- Event
- Event 80163
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5712
- Official record key
device-enforcement:Z-2344-2018
Official wording
Reason: There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Code information: Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-5233, 2616-0165-5232, 2616-0165-5611, 2616-0165-5610, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6275, 2616-0165-6220, 2616-0165-6221, 2616-0165-6219, 2616-0165-6276, 2616-0165-6791, 2616-0165-6832, 2616-0165-6792, 2616-0165-6787, 2616-0165-7225, 2616-0165-7226, 2616-0165-7223, 2616-0165-7214, 2616-0165-7222
Distribution pattern: Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden
Derived failure modes
-
Unknown
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.