VITEK¿ 2 Compact 30 recalled over mold contamination

Recall date

July 12, 2017

Source

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

Official notice title

Biomerieux Inc recalls VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent car…

Recall number

Z-3076-2017

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

Worldwide

Why it was recalled

Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

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 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.