RecallRadar

FDA Device recall Z-0130-2015

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Nu…

On 2014-11-05 the FDA classified a Class II recall of ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Nu… by Siemens Healthcare Diagnostics, citing ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0130-2015
ClassificationClass II
Statusterminated
Initiated2012-10-09
Published2014-11-05
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)

Reason

Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

Identifiers

code_infoLot numbers: 83496A22 88716A22 95040822 95889A22 Exp. 01/19/2013

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-0130-2015%22

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