Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an… — Class II medical device recall Z-1184-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-04-04, distributed nationwide. An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient
| Recall number | Z-1184-2018 |
|---|---|
| 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 | 2017-11-09 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, DK, ES, FR, IT, NL, SK |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00842768026492 |
| Lot numbers | 7CD076 |
| Model numbers | 7CD076, KC646 |
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.
Reason for recall
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.
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-1184-2018. 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.