Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista® CHEM 1 CAL lots 5GM081 and 5GM082. |
| 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 |
| Quantity | 9,935 units |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally to Australia, Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Qatar, Saudi Arabia, South Korea, Slovakia, Slovenia, Spain, and Switzerland. |
| Initiated | 2016-09-15 |
| Classified | 2016-11-21 |
| Terminated | 2018-05-31 |
| Recall number | Z-0652-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0652-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75484/
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