Device product
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
Z-1216-2017
Product summary
- Event
- Event 76293
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,147 units
- Official record key
device-enforcement:Z-1216-2017
Official wording
Reason: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 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: Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061
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 Vista Enzyme 2 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.