RecallRadar

FDA Device recall Z-0214-2015

ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems)…

On 2014-11-26 the FDA classified a Class III recall of ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems)… by Siemens Healthcare Diagnostics, citing stability of the ADVIA Centaur Cleaning Solution is not assured.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0214-2015
ClassificationClass III
Statusterminated
Initiated2014-09-12
Published2014-11-26
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.

Reason

Stability of the ADVIA Centaur Cleaning Solution is not assured

Identifiers

code_infoLot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014

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-0214-2015%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.