Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum — Class II medical device recall Z-0290-2018
Terminated recall by Remel Inc, reported 2018-01-03, distributed nationwide. The serum may fail to agglutinate within the specified minimum reaction time.
| Recall number | Z-0290-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2017-12-08 |
| Classified | 2017-12-26 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2020-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 237 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 50560805009592 |
| Lot numbers | 1465528, 1465529, 1738564, 1738565, 1847285, 1847290, 1947930, 1957305, 1971308, 1984639, 2118879, 2161363, 2173683 |
| Model numbers | R30164201, ZH01 |
Product
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Reason for recall
The serum may fail to agglutinate within the specified minimum reaction time.
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-0290-2018. 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.