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 | An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay. |
| Product | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System. |
| Quantity | 989 (681 USA/308 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland. |
| Initiated | 2017-11-09 |
| Classified | 2018-03-26 |
| Terminated | 2020-06-08 |
| Recall number | Z-1184-2018 |
| 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-1184-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79412/
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