Recall Z-2779-2016— Biomerieux France Chemin De L'Or
Class III · Terminated
Class III FDA medical device recall by Biomerieux France Chemin De L'Or, initiated 2016-04-15, terminated 2017-07-21. It names one FDA 510(k) clearance: K073091. 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.. Reason: Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials..
- Recalling firm
- Biomerieux France Chemin De L'Or
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-04-15
- Terminated
- 2017-07-21
- Firm location
- Marcy L'Etoile, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.