Z-2779-2016 Class III Terminated
FDA device recall Z-2779-2016 was initiated by Biomerieux France Chemin De L'Or on April 15, 2016 and is designated Class III. Reason for recall: Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. The recall status is terminated (terminated July 21, 2017). Affected quantity: 229 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- April 15, 2016
- Termination Date
- July 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 229 kits
Product Description
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.
Reason for Recall
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
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.
Code Information
Reference number: 30449-01, Lot #1004474560.