FDA Enforcement
Class II
Terminated
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.
Recall: Z-2920-2020
·
Reported September 9, 2020
Enforcement
- Recall Number
- Z-2920-2020
- Event ID
- 86109
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Remel Europe Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 9, 2020
- Initiation Date
- July 23, 2020
- Classification Date
- August 28, 2020
- Termination Date
- March 22, 2022
- Address
- Clipper Boulevard West, N/A, Dartford, N/A, N/A, United Kingdom
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
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 Info
Lot # 2407976
Distribution
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.
Quantity
79 units