Recall Z-1516-2012 ยท NBC Test, Natriuretic Peptide
Siemens Healthcare Diagnostics, Inc.
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 a
| Date | May 10, 2012 (initiated Apr 5, 2012) |
| Status | Terminated |
| Reason | 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 | 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 inventor |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM Dade Behring, Inc., Aug 17, 2007 |