Thermo Scientific Remel Bordetella pertussis Agglutinating Serum… — Class II medical device recall Z-2920-2020
Terminated recall by Remel Europe Ltd., reported 2020-09-09, distributed nationwide. Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulti
| Recall number | Z-2920-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Europe Ltd., Dartford, N/A, United Kingdom |
| Recall initiated | 2020-07-23 |
| Classified | 2020-08-28 |
| Reported by FDA | 2020-09-09 |
| Terminated | 2022-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 79 units |
| UPC / GTIN / UDI-DI | 05056080501826 |
| Lot numbers | 2407976 |
Product
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.
Reason for recall
Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3
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-2920-2020. 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.