Recall Z-2817-2018— bioMerieux, Inc.

Name: FDA recall Z-2817-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Class I · Terminated

Class I FDA medical device recall by bioMerieux, Inc., initiated 2018-01-26, terminated 2019-05-20. It names one FDA 510(k) clearance: K053097. Product: bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.. Reason: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product..

Recalling firm: bioMerieux, Inc.
Classification: Class I
Status: Terminated
Initiated: 2018-01-26
Terminated: 2019-05-20
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K053097 — VITEK 2 GRAM POSITIVE CEFOXITIN SCREENbioMerieux, Inc.·cleared 2005-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

Reason for recall

Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.