Device product
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
Z-1217-2017
Product summary
- Event
- Event 76293
- Status
- Terminated
- Classification
- Class III
- Quantity
- 24,940.00
- Official record key
device-enforcement:Z-1217-2017
Official wording
Reason: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
Code information: Product Lot: 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
Distribution pattern: Distributed throughout the United States
Derived failure modes
-
Unknown
Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.