VITEK 2 Gram Negative test kits containing colistin (cs01n)
Reported: August 2, 2017 Initiated: May 16, 2017 #Z-2770-2017
Product Description
VITEK 2 Gram Negative test kits containing colistin (cs01n)
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).
Details
- Recalling Firm
- Biomerieux Inc
- Units 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, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
VITEK 2 Gram Negative test kits containing colistin (cs01n). Recalled by Biomerieux Inc. Units affected: 1,520,000 cards.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2017. Severity: Moderate. Recall number: Z-2770-2017.
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