Health product recall

Vitek 2 System - Susceptibility Test Cards

Brand(s)
Last updated

Summary

Product
Vitek 2 System - Susceptibility Test Cards
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Vitek 2 System - Susceptibility Test Cards 1402761504 1412754504 423340 423341

Issue

The St. Louis manufacturing site discovered a calculation error in the master formulation for ceftriaxone (cro02n) used in specific card lots. The error was related to the ceftriaxone concentration used in two wells of the test card.

Recall start date: March 15, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Biomerieux, Inc.
100 Rodolphe Street, Durham, North Carolina, United States, 27712
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75312

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