Z-2920-2020 Class II Terminated
FDA device recall Z-2920-2020 was initiated by Remel Europe Ltd. on July 23, 2020 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated March 22, 2022). Affected quantity: 79 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2020
- Initiation Date
- July 23, 2020
- Termination Date
- March 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 units
Product 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 for Recall
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
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.
Code Information
Lot # 2407976