Dimension Vista Enzyme 1 Calibrator — Class II medical device recall Z-1076-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-03-05, distributed nationwide. Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecisio
| Recall number | Z-1076-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2014-01-06 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,496 |
| Lot numbers | 3FD034, 3HD012 |
| Expiration dates | 2014-06-17, 2014-09-01 |
Product
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
Reason for recall
Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
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-1076-2014. 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.