VITEK Positive Susceptibility Test Cards recalled over mold contamination

Recall date

February 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biomerieux Inc recalls VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Ca…

Recall number

Z-1596-2016

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

Worldwide Distribution to China  Taiwan region; No US/military/government distribution.

Why it was recalled

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is 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 to antimicrobial agents when used as instructed in the Product Information manual.