medical Class II Updated 2020-09-09

Remel Europe Ltd. recalls Thermo Scientific Remel Bordetella pertussis Agglutinating S

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 2407976
View official government recall

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