RecallRadar

FDA Device recall Z-2256-2016

ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0…

On 2016-07-27 the FDA classified a Class II recall of ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0… by Siemens Healthcare Diagnostics, citing eight (8) issues were identified which may affect the results generated by the system software version.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2256-2016
ClassificationClass II
Statusterminated
Initiated2016-05-26
Published2016-07-27
Last updated2026-09-13 11:54 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

Reason

Eight (8) issues were identified which may affect the results generated by the system software version.

Identifiers

code_infonone

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2256-2016%22

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