Z-2171-2013Class II

ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the...

Name: Z-2171-2013 ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2013-07-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-07-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood... on 2013-07-25. FDA classified it as Class II and gives the reason as "Calibration failures and/or significant negative shifts in quality control (QC) and patient results". 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-2171-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Posted: 2013-09-10
Terminated: 2015-06-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Siemens sent an Urgent Medical Device Correction letter on July 26, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. an Urgent Field Safety Notice was sent to all domestic customers via Federal Express. On July 25, 2013 this notice was sent to all OUS customers via hard copy, email, and/or fax as determined by each country's local regulations and procedures. These notices inform the customer that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (QC) and patient results. If customers have an alternate lot of the ADVIA Centaur or ADVIA Centaur CP Folate assay, they are instructed that this lot should be used for future testing. However if no alternative lot is available, quality control (QC) results should be obtained for each individual ReadyPack as a QC or calibration is an indication of an affected pack. An affected pack must be replaced with a different Folate ReadyPack where a valid calibration and acceptable QC values are obtained. These notices should be reviewed by the facility's laboratory or medical director, though no look back is required. Customers were instructed that Fedex Return Receipts will be used to confirm that the customers received the UMDC. Customers with questions were instructed to contact their local Technical Support Provider or Distributor. For questions regarding this recall call 508-668-5000.
Quantity in commerce: 488
Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
Product codes and lots: 22298218

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2171-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2169-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2170-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2171-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2172-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10

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)