FDA Device recall Z-2920-2020
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordete…
- FDA Device
- Class II
- terminated
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class II recall of Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordete… by Remel Europe, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2920-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-23 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Remel Europe |
| Distribution | US |
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
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
Identifiers
| code_info | Lot # 2407976 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2920-2020%22
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