Remel Haemophilus Test Medium — Class II medical device recall Z-1425-2021
Ongoing recall by Remel Inc, reported 2021-04-21, distributed nationwide. When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth
| Recall number | Z-1425-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2021-03-10 |
| Classified | 2021-04-13 |
| Reported by FDA | 2021-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 19 units |
| Lot numbers | 220711 |
| Model numbers | R01503 |
| Expiration dates | 2021-02-17 |
Product
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Reason for recall
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
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-1425-2021. 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.