FDA
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.
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
On July 23, 2020, Thermo Scientific issued a Medical Device field action recall on behalf of the Foreign Manufacturer of the affected product, Remel Europe Ltd . The notification states the following action to be taken:
1. The firm requests that you destroy any remaining inventory of the lot listed and contact Technical Services regarding any necessary replacements.
2. Requirement for review of reported test results should be determined by the appropriate technical expert.
3. Please keep this notification on file.
4. Complete the accompanying Acknowledgment Form upon receipt and return to MBD.vigilance@thermofisher.com.
If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.