FDAClass IIISeptember 21, 2016

VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP recall

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…

Why was VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP recalled?

Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Reference number: 30449-01, Lot #1004474560.

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…
Recalling firm
Biomerieux France Chemin De L'Or
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.
Recall date
September 21, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls