Z-2739-2015Class II

ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell...

Name: Z-2739-2015 ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2015-07-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-07-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of 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... on 2015-07-27. FDA classified it as Class II and gives the reason as "Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2739-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Posted: 2015-09-04
Terminated: 2016-02-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An Urgent Medical Device Recall (UMDR) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 27, 2015 to be delivered to customers on July 28, 2015. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 27, 2015. These notices inform the customer to discontinue use of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent kit lots 54942, 56230 and 70673 and dispose of the remaining inventory per local regulations. The ADVIA Centaur Systems Folate red blood cell sample and control negative bias is minimal in the lower range of the assay and is more pronounced with increasing folate concentrations. The negative bias could lead to a misclassification of a patient as folate deficient. Siemens does not recommend a look back of previously tested patients. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall and completed the required actions.
Quantity in commerce: 466
Distribution: Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
Product codes and lots: Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2739-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2739-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-04

Product code CGN

K010050Class IIAdvia Centaur and Acs: 180 Folate ImmunoassayBayer Diagnostics Corp. / cleared 2001-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)