FDA recall Z-3075-2017

Product

VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

Reason for recall

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.

Distribution

Worldwide

Key facts

Status

Terminated

Initiation date

2017-07-12

Report date

2017-09-06

Termination date

2020-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3075-2017