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 | There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test. |
| Product | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. |
| Quantity | 1,043 units |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution. |
| Initiated | 2021-11-09 |
| Classified | 2021-12-27 |
| Terminated | 2025-02-10 |
| Recall number | Z-0422-2022 |
| 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-0422-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89041/
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