FDA Device recall Z-1078-2016
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For i…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For i… 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-1078-2016 |
| 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 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
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Identifiers
| code_info | Lot code/ Exp.Date: 86344A42 May 9, 2016; 55437A42 May 9, 2016; 54801A42 May 9, 2016; 53651A42 May 9, 2…Lot code/ Exp.Date: 86344A42 May 9, 2016; 55437A42 May 9, 2016; 54801A42 May 9, 2016; 53651A42 May 9, 2016; 53625A42 May 9, 2016; 15610A43 November 27, 2016; 18375A43 November 27, 2016; 24990A43 November 27, 2016; 38988A43 November 27, 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-1078-2016%22
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