Recall Z-0229-2015 ยท NBC Test, Natriuretic Peptide
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
| Date | Nov 19, 2014 (initiated Oct 6, 2014) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label. |
| Root cause | Labeling mix-ups |
| Action | A Customer Notification (CN) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 03, 2014 to be delivered to customers on October 06, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 06, 2014. These notices inform the customer of the potential to receive an ADVIA Centaur BNP ReadyPack with a FT4 human-readable side label. Siemens instructs customers to inspect their inventory and discard any BNP Readypacks with a FT4 side label. In addition, Siemens in |
| Quantity | 100 test - 4,600 kits; 500 test - 1,878 kits |
| Distribution | Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian F |
| 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 |