Device product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
Z-1664-2023
Product summary
- Event
- Event 92245
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 132 units
- Official record key
device-enforcement:Z-1664-2023
Official wording
Reason: Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Code information: UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
Distribution pattern: Nationwide Foreign: Brazil, Chile, Colombia
Derived failure modes
-
Unknown
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing