Recall Z-0506-2013 ยท NBC Test, Natriuretic Peptide
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment o
| Date | Dec 11, 2012 (initiated Nov 14, 2012) |
| Status | Terminated |
| Reason | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
| Root cause | Device Design |
| Action | Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers. These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature range to 20 -25 degrees C and for the DHEAS assay to reduce the instrument operating temperature range to 18 -26 degrees C when these assays are being used. These notices also direct customers to review the contents of the co |
| Quantity | 100 test=24291 and 500 test= 9679 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031038 | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY Bayer Healthcare, LLC, Jun 23, 2003 |