RecallRadar

FDA Device recall Z-1659-2014

ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS

On 2014-06-04 the FDA classified a Class II recall of ADVIA Centaur Systems BRAHMS PCT 100 test Sold only 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-1659-2014
ClassificationClass II
Statusterminated
Initiated2014-04-10
Published2014-06-04
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.

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: 020 11 July 2014 021 15 December 2014 022 24 February 2015 023 25 February 2015 024 03 July 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-1659-2014%22

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