FDA Device recall Z-2899-2016
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglob…
- FDA Device
- Class II
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class II recall of Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglob… by Siemens Healthcare Diagnostics, citing failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2899-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-08 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Reason
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Identifiers
| code_info | Kit Lots ending in 63 and 64 as follows: 65710A63, 77825A63, 99481A64, 08835A64, 22955A64 |
|---|
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-2899-2016%22
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