Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack… — Class II medical device recall Z-1078-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-03-16, distributed nationwide. ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
| Recall number | Z-1078-2016 |
|---|---|
| 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 | 2016-02-04 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | potency |
| Lot numbers | 15610A43, 18375A43, 24990A43, 38988A43, 53625A42, 53651A42, 54801A42, 55437A42, 86344A42 |
| Model numbers | 04634762, 10321075 |
Product
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Reason for recall
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone 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-1078-2016. 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.