Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vite

FDA device recall Z-1403-2015 · posted 2015-04-08 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

LTW

Quantity affected

1505 cartons

Distribution

Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

Date initiated

2015-02-25

Date posted

2015-04-08

Date terminated

2017-03-22

Location

Hazelwood, MO