Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator — Class II medical device recall Z-0652-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-11-30, distributed nationwide. Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vis
| Recall number | Z-0652-2017 |
|---|---|
| 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 | 2016-09-15 |
| Classified | 2016-11-21 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2018-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BS, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, NL, NO, NZ, PT, QA, SA, SI, SK |
| Quantity | 9,935 units |
| Lot numbers | MGM081, MGM082 |
Product
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System
Reason for recall
Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.
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-0652-2017. 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.