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Terminated

VITEK 2 Gram Negative test kits containing colistin (cs01n)

FDA Recall Z-2770-2017 · Posted 2017-06-27

Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodePTJ
Date Initiated2017-05-16
Date Terminated2019-06-19
Product Quantity1,520,000 cards

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).

Firm Action

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

Distribution Pattern

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, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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