The Enzyme 2 Calibrator is an in vitro diagnostic product for the… — Class III medical device recall Z-1216-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-02-22, distributed nationwide. Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vi
| Recall number | Z-1216-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-05-05 |
| Classified | 2017-02-16 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 13,147 units |
| Reason classes | potency |
| Lot numbers | 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1216-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.