Class II — Biomerieux Inc
| Recalling firm | BIOMERIEUX SA |
|---|---|
| Registered facility | View this company's 16 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| Product | VITEK 2 Gram Negative test kits containing colistin (cs01n) |
| Quantity | 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, Venezu… |
| Initiated | 2017-05-16 |
| Classified | 2017-07-27 |
| Terminated | 2019-06-19 |
| Recall number | Z-2770-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biomerieux Inc (Z-2770-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77373/
Alerts for BIOMERIEUX SA
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.