VITEK 2 System Susceptibility and VITEK 2 Compact 30 and 60 System - Susceptibility Test Cards (2018-10-15)

Starting date:

October 15, 2018

Posting date:

November 15, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68210

• 
  Reason
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  Affected products

Affected products

1. VITEK 2 Compact 30 System - Susceptibility Test Cards
2. VITEK 2 Compact 60 System - Susceptibility Test Cards
3. VITEK 2 System - Susceptibility Test Cards

Reason

Customers in Europe reported false resistant Ceftriaxone results for Streptococcus anginosus and Streptococcus constellatus strains when using VITEK 2 AST-ST01 and AST-ST03 cards and VITEK 2 Systems Software 8.01 with EUCAST breakpoints. These false resistant results were reproduced internally by testing customer strains. A Ceftriaxone MIC overestimation was observed compared to the reference result. An internal study confirmed the performance of Streptococcus anginosus, Streptococcus constellatus, and Streptococcus intermedius had shifted for Ceftriaxone. With EUCAST Global European-based breakpoints, having no Intermediate MIC, this may constitute a category difference. Many strains demonstrated a result of MIC=1 (R) with EUCAST breakpoints, when an MIC=1 remains susceptible (S) for CLSI, Global CLSI-based and FDA breakpoints. The VITEK 2 Ceftriaxone test is included on all AST-ST cards intended for testing streptococci. All lots of AST-ST01, AST-ST02, and AST-ST03 are impacted and are distributed globally.

Affected products