FDA Device recall Z-1515-2013
ADVIA Centaur¿ iPTH Calibrator 6 pk
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of ADVIA Centaur¿ iPTH Calibrator 6 pk 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-1515-2013 |
| 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 Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Reason
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Identifiers
| code_info | Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 20…Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 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-1515-2013%22
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