FDA Device recall Z-1513-2013
ADVIA Centaur¿ iPTH ReadyPack Assay 500 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 500 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-1513-2013 |
| 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 500 Tests; REF 10492369, 10493615, 1049361. 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 Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1…Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 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-1513-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.