VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards. Priority 2 – Warning

All VITEK® 2 AST Test Cards manufactured before 16 March 2017 are affected.Images with examples of a defective pouch together with a spreadsheets of lot numbers and expiry dates of affected products is listed both in the manufacturer’s Field Safety Notice and in the pdf file attached to this alert at the bottom of the page.

BIOMERIEUX

bioMérieux: VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards referenced in Appendix A

VITEK 2 Identification / Antimicrobial Susceptibility Test Cards. An in vitro diagnostic medical device (IVD)Multiple Products and Lot NumbersARTG Numbers: 215320, 196634, 212784

VITEK® 2 IDENTIFICATION / ANTIMICROBIAL SUSCEPTIBILITY TEST CARDS, Biomerieux Inc

Model: , Affected: VITEK 2 GN ID, VITEK 2 GP ID, VITEK 2 BCL ID, VITEK 2 NH ID, VITEK 2 ANC ID, VITEK 2 AST GP69, VITEK 2 AST P612, VITEK 2 AST ST01, VITEK 2 AST GN65, VITEK 2 AST N246, VITEK 2 AST GN82, VITEK 2 AST YS07, VITEK 2 AST N311, VITEK 2 AST GP76

VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards. Priority 2 – Warning.

Medical Device Safety Alert: BioMérieux VITEK 2 Identification / Antimicrobial Susceptibility Test Cards

Immunology and Microbiology Devices

Medical Device Safety Alert: Medical Device Safety Alert

VITEK® 2 Gram- Positive Identification Test Kit. Priority 2 – Warning.

Model: , Affected: VITEK® 2 GP ID Lots #2420192403, 2420198203

Recall of batches 2420240403 and 2120303403 of the in vitro diagnostic medical device VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit (code 21342)

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)Batch/Lot Number: 2420192403Expiry: 06 June 2018Batch/Lot Number: 2420198203Expiry: 12 June 2018ARTG Number: 215320

VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit, bioMérieux Inc.

BIOMERIEUX: VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit

Alert lot vitek 2 - biomerieux

21342 | See FSN

IVD: Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit