| Class 3 Device Recall Vitek 2 ASTP635 REF 416 911 |  |
Date Initiated by Firm | February 25, 2015 |
Date Posted | April 08, 2015 |
Recall Status1 |
Terminated 3 on March 22, 2017 |
Recall Number | Z-1401-2015 |
Recall Event ID |
70645 |
Product Classification |
Susceptibility test cards, antimicrobial - Product Code LTW
|
Product | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD.
Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. |
Code Information |
lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15 |
Recalling Firm/ Manufacturer |
Biomerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
|
For Additional Information Contact | Ryan LeMelle 314-731-8526 |
Manufacturer Reason for Recall | The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. |
FDA Determined Cause 2 | Employee error |
Action | Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioMrieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioMrieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526. |
Quantity in Commerce | 10409 cartons |
Distribution | Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution. |
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.
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