VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of th
FDA device recall Z-2779-2016 · posted 2016-09-10 · Terminated
Recall details
- Recalling firm
- Biomerieux France Chemin De L'Or
- Reason for recall
- Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- NBC
- Quantity affected
- 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.
- Date initiated
- 2016-04-15
- Date posted
- 2016-09-10
- Date terminated
- 2017-07-21
- Location
- Marcy L'Etoile, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS NT-PROBNP ASSAY, MODEL: 30 449 (K073091) | bioMerieux, Inc. | 2008-02-29 |