ADVIA Chemistry Enzyme 2 Calibrator — Class III medical device recall Z-1712-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-04-12, distributed nationwide. Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient resul
| Recall number | Z-1712-2017 |
|---|---|
| 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 | 2017-02-23 |
| Classified | 2017-04-04 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, CO, CZ, DE, DK, ES, FR, GB, GR, HK, IL, KR, NL, NO, PT, SE, SI |
| Quantity | 314 calibrators |
| Lot numbers | 6JD079, 6MD042 |
Product
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
Reason for recall
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
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-1712-2017. 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.