RecallRadar

FDA Device recall Z-1658-2014

ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS

On 2014-06-04 the FDA classified a Class II recall of ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS by Siemens Healthcare Diagnostics, citing samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1658-2014
ClassificationClass II
Statusterminated
Initiated2014-04-10
Published2014-06-04
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

Reason

Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Identifiers

code_infoKit lots ending in/Exp Date: 050 08 August 2014 051 20 September 2014 052 11 December 2014 053 10 December 2014 054 07 March 2015

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-1658-2014%22

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