Z-0229-2015Class III

ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic...

Name: Z-0229-2015 ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-10-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-10-06 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA... on 2014-10-06. FDA classified it as Class III and gives the reason as "Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0229-2015
Classification: Class III
Status: Terminated
Initiated: 2014-10-06
Posted: 2014-11-19
Terminated: 2015-07-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
Product code: NBC Test, Natriuretic Peptide
Reason for recall: Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: A Customer Notification (CN) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 03, 2014 to be delivered to customers on October 06, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 06, 2014. These notices inform the customer of the potential to receive an ADVIA Centaur BNP ReadyPack with a FT4 human-readable side label. Siemens instructs customers to inspect their inventory and discard any BNP Readypacks with a FT4 side label. In addition, Siemens informs customers the end labels of the affected ReadyPacks correctly identify the pack as BNP and Siemens has confirmed the reagent within these packs is BNP Reagent. Therefore valid BNP results will be generated when calibrating and running quality control or patient samples. Fax-back forms will be used to confirm that the customers received the notification. 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 Customer Notification and completed the required actions.
Quantity in commerce: 100 test - 4,600 kits; 500 test - 1,878 kits
Distribution: Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.
Product codes and lots: Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0229-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0229-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19

Product code NBC

K031038Class IIAdvia Centaur B-Type Natriuretic Peptide (Bnp) AssayBayer Healthcare, LLC / cleared 2003-06-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)