Remel Haemophilus Test Medium — Class II medical device recall Z-2038-2023
Ongoing recall by Remel, Inc, reported 2023-07-05, distributed nationwide. The test medium may not perform as intended.
| Recall number | Z-2038-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2023-05-31 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,296 packages |
| UPC / GTIN / UDI-DI | 00848838001932, 00848838004476 |
| Lot numbers | 619859, 623548, 629086, 629087, 631001, 631958, 634496, 635369, 641527, 644542, 645950, 648004, 648125, 651372 |
| Model numbers | 01503, R01503, R04033 |
| Expiration dates | 2023-03-23, 2023-03-28, 2023-03-31, 2023-04-11, 2023-04-12, 2023-04-18, 2023-04-19, 2023-05-02, 2023-05-09, 2023-05-11, 2023-05-16, 2023-05-18, 2023-05-23 |
Product
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Reason for recall
The test medium may not perform as intended.
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-2038-2023. 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.