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Remel Europe Ltd. recalls Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Pro

Recalled September 9, 2020 · FDA recall Z-2920-2020 · Remel Europe

Hazard
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 · FDA Class II
Units
79 units
Sold at
Worldwide distribution - US Nationwide distribution including in the states of MO, CA and the countries of CA, AT, BO, CN, CZ, GB, GM, HK, IE, IT, MX, MY, NL,OM, SA.

Description

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

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.
Manufacturer(s)
Remel Europe Ltd.
Made in
United Kingdom

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Remel Europe Ltd. recalls Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Pro | RecallWatchUSA