Z-1516-2012

Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT...

Name: Z-1516-2012 Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-04-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-04-05 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for... on 2012-04-05. The reason FDA records is "Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific SCS Pro-BNP lots listed. This issue only causes the slope error failures...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1516-2012
Status: Terminated
Initiated: 2012-04-05
Posted: 2012-05-10
Terminated: 2013-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.
Product code: NBC Test, Natriuretic Peptide
Reason for recall: Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific SCS Pro-BNP lots listed. This issue only causes the slope error failures but does not affect patient results when the calibration is within specifications.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, SIEMENS, sent a "Urgent Field Safety Notice" dated March, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue use of the lots once revised expiration date occurs; contact their local Siemens Customers Service Center at 888-588-3916 for replacement; complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the TECHNICAL SOLUTIONS CENTER at (302) 631-8467 as soon as possible, and forward this notification to anyone to whom they may have distributed this product. The remaining inventory at the firm was destroyed. If you have any technical questions regarding this information, please contact the Siemens Technical Solutions Center at 800-405-6473.
Quantity in commerce: 1,899 cartons
Distribution: Nationwide distribution: USA including states of: AK, AR, CA, CO, CT, DC, FL, HI, ID, IN, IL, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NH, NM, ND, NY, OH, OK, OR, PA, SD, TX, UT, VT, WA, WV, WI, and WY.
Product codes and lots: Lot numbers 211214002, exp 04/28/2012; 211227002, exp 05/11/2012; 211283002, 07/06/2012; 211297002, 07/20/2012; 211339002, 08/31/2012; 212003002, exp 09/29/2012; and 212023002, exp 10/19/2012.

Product code NBC

K071834Class IIStratus Cs Acute Care Nt-Probnp Testpak, Model CpbnpmDade Behring, Inc. / cleared 2007-08-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)