Date Initiated by Firm |
October 14, 2013 |
Date Posted |
August 06, 2014 |
Recall Status1 |
Terminated 3 on August 28, 2017 |
Recall Number |
Z-2152-2014 |
Recall Event ID |
68749 |
Product Classification |
in vitro diagnostic PSA - Product Code MTF
|
Product |
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma. |
Code Information |
Lot 1001904130 |
Recalling Firm/ Manufacturer |
BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
|
For Additional Information Contact |
Alan Bergold, PhD 919-620-2000
|
Manufacturer Reason for Recall |
Product is not approved or authorized for distribution in the US.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
A letter was issued on October 14, 2013 to consignees requesting the consignee to check their stock and destroy all kits of the VIDAS TPSA ref. 30428. The letter also requested that the consignee notify their accounts of the recall. An acknowledgment form was also included with the letter which is to be returned to BioMerieux. |
Quantity in Commerce |
1902 |
Distribution |
FL, LA, MI, MS, NV, OH, OK, TN, TX |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|