FDA Device recall Z-0515-2018
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0515-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-07 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | n/a |
Product
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Reason
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
Identifiers
| code_info | Lot Numbers: 00387A21, 16673A21, 36243A21; 00388A21, 15448A21, 51211A21; 20640A21; 51024A21. Expiration Date: 2018-03-08 |
|---|
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-0515-2018%22
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