Recall Z-2779-2016 ยท NBC Test, Natriuretic Peptide
Biomerieux France Chemin De L'Or
VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestiv
| Date | Sep 10, 2016 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. |
| Root cause | Packaging |
| Action | bioMerieux. sent an Urgent Product Removal Notice letter dated April 26, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check for affected products in their inventory and discard the incomplete products. Customers were asked to complete the attached Acknowledgement Form and return it via fax to bioMerieux. For questions contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666. |
| Quantity | 229 kits |
| Distribution | US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073091 | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 bioMerieux, Inc., Feb 29, 2008 |