FDA Device recall Z-1970-2013
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack)
- FDA Device
- Class III
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class III recall of ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack) by Siemens Healthcare Diagnostics, citing calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1970-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-06-28 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
Reason
Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
Identifiers
| code_info | REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2013%22
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