FDA Device recall Z-1216-2017
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Ami…
- FDA Device
- Class III
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class III recall of The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Ami… by Siemens Healthcare Diagnostics, citing 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 pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1216-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-05 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2017%22
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