FDA Device recall Z-1512-2013
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests by Siemens Healthcare Diagnostics, citing iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1512-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-14 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Reason
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Identifiers
| code_info | Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011 |
|---|
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-1512-2013%22
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