Device product
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
Z-2266-2024
Product summary
- Event
- Event 94770
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1000
- Official record key
device-enforcement:Z-2266-2024
Official wording
Reason: VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Code information: Lot Code: Model No 6801754; UDI-DI 10758750007004; Lot Number 01-1645; Expiration Date: 05-Jul-2024
Distribution pattern: Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Spain, Singapore, Sweden, The Netherlands, United Kingdom.
Derived failure modes
-
Unknown
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.