Device 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.
Z-2779-2016
Product summary
- Event
- Event 73989
- Status
- Terminated
- Classification
- Class III
- Quantity
- 229 kits
- Official record key
device-enforcement:Z-2779-2016
Official wording
Reason: Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Code information: Reference number: 30449-01, Lot #1004474560.
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
packaging error