VITEK 2 Gram Negative test kits containing colistin (cs01n)

FDA device recall Z-2770-2017 · posted 2017-06-27 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).

Action taken

Customers were notified on or about 05/16/2017 and then notified again with an updated letter. Instructions to customers included requesting that the attached acknowledgement form be completed, distribute the recall notification to customers, and provide the notice to future customers.

Root cause

Other

Status

Terminated

Product code

PTJ

Quantity affected

1,520,000 cards

Distribution

Domestic: NC. Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia

Date initiated

2017-05-16

Date posted

2017-06-27

Date terminated

2019-06-19

Location

Hazelwood, MO