Recall Z-1216-2017
Siemens Healthcare Diagnostics, Inc. · initiated May 5, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.
Details
- Recall number
- Z-1216-2017
- Initiated
- May 5, 2016
- Terminated
- February 2, 2018
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 13,147 units
- Distribution
- Distributed throughout the United States
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1217-2017 Class III | The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine…Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension… | 05/05/2016Terminated |