Recall Z-2770-2017— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2017-05-16, terminated 2019-06-19. FDA's recall record names no specific 510(k) clearance for this event. Product: VITEK 2 Gram Negative test kits containing colistin (cs01n). Reason: 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)..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-16
- Terminated
- 2019-06-19
- Firm location
- Hazelwood, MO, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.