Recall Z-2920-2020— Remel Europe Ltd.
Class II · Terminated
Class II FDA medical device recall by Remel Europe Ltd., initiated 2020-07-23, terminated 2022-03-22. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Remel Europe Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-23
- Terminated
- 2022-03-22
- Firm location
- Dartford, N/A, United Kingdom
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.