Siemens Calibrator E — Class II medical device recall Z-0164-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-11-12, distributed nationwide. Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Proges
| Recall number | Z-0164-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2014-09-26 |
| Classified | 2014-10-31 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2016-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AT, BE, BG, BH, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IQ, IR, IT, JO, LB, LT, LU, LV, MA, MT, NL, NO, OM, PK, PL, PT, QA, RO, RS, SA, SE, SK, TR |
Product
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Reason for recall
Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.
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-0164-2015. 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.