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Recall Observatory FDA recall evidence

Device 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.

Z-2920-2020

July 23, 2020

Class II

Product summary

Firm
Remel Europe Ltd.
Event
Event 86109
Status
Terminated
Classification
Class II
Quantity
79 units
Official record key
device-enforcement:Z-2920-2020

Official wording

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

Code information: Lot # 2407976

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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