Recall Z-2779-2016
Biomerieux France Chemin De L'Or · initiated April 15, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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 congestive heart failure.
Codes / lots: Reference number: 30449-01, Lot #1004474560.
Reason for recall
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-2779-2016
- Initiated
- April 15, 2016
- Posted by FDA
- September 10, 2016
- Terminated
- July 21, 2017
- Product code
- NBC – Test, Natriuretic Peptide
- 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.
- Recalling firm
- Biomerieux France Chemin De L'Or, Marcy L'Etoile