FDAFDA · Food and drugs·Recall number Z-2920-2020
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.
Published September 9, 2020 · Recall initiated: July 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Europe Ltd.
- Distributor
- 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.
- Lot
- Lot # 2407976
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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