RecallRadar

FDA Device recall Z-2739-2015

ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent

On 2015-09-16 the FDA classified a Class II recall of ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent by Siemens Healthcare Diagnostics, citing low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2739-2015
ClassificationClass II
Statusterminated
Initiated2015-07-27
Published2015-09-16
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.

Reason

Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

Identifiers

code_infoLot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17

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-2739-2015%22

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