RAPID 20 E — Class II medical device recall Z-0422-2022
Terminated recall by Biomerieux Inc, reported 2022-01-05, distributed nationwide. There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a
| Recall number | Z-0422-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2021-11-09 |
| Classified | 2021-12-27 |
| Reported by FDA | 2022-01-05 |
| Terminated | 2025-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,043 units |
| Lot numbers | 1008332150, 1008787180 |
| Model numbers | 20701 |
| Expiration dates | 2022-04-20, 2022-12-12 |
Product
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0422-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.