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U.S. Department of Health and Human Services

Class 2 Device Recall Stratus(R) CS Acute care(TM) NT

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 Class 2 Recall
Stratus(R) CS Acute care(TM) NT
see related information
Date Posted May 10, 2012
Recall Status1 Terminated on March 19, 2013
Recall Number Z-1516-2012
Recall Event ID 61661
Premarket Notification
510(K) Number
K071834 
Product Classification Test,Natriuretic Peptide - Product Code NBC
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.
Code Information 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.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Aydee Crawford
302-631-6312
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBC and Original Applicant = DADE BEHRING, INC.
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