Z-2053-2018Class II

ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)

Name: Z-2053-2018 ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-12-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-12-18 / Open, Classified / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests) on 2017-12-18. FDA classified it as Class II and gives the reason as "In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2053-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-12-18
Posted: 2018-06-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
Product code: NBC Test, Natriuretic Peptide
Reason for recall: In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees are asked to return the response form and follow the instructions pertaining to their system and assays: Actions for ALL ADVIA Centaur Systems: Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected kits are present on the system. Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. Actions for ADVIA Centaur XPT system: If you intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, you must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. Please perform the attached steps to restart the workstation. Actions for ADVIA Centaur CP system: If any of the affected kit lots have been in use on the system, you must manually track the time that the Multi-Diluent 15 has been in use on board the system. Replace the ancillary pack of Multi-Diluent 15 every 7 days when used, until a follow-up communication is received from Siemens stating this issue has been resolved.
Quantity in commerce: 21,687
Distribution: Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Israel Italy¿¿¿¿¿¿¿¿¿¿ Japan Latvia¿¿¿¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Netherlands¿¿¿¿ New Zealand Norway¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿
Product codes and lots: Lot Numbers ending in: 192,193,196

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2053-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2053-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-06-13	2018-06-01
Z-2054-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-06-13	2018-06-01

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)