FDA Device recall Z-1079-2016
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibra…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibra… by Siemens Healthcare Diagnostics, citing ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1079-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-04 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 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
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Identifiers
| code_info | Lot codes/Exp Date: 91005A42 May 9, 2016; 53698A42 May 9, 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1079-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.