FDA recall Z-2920-2020

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.

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

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.

Key facts

Status

Terminated

Initiation date

2020-07-23

Report date

2020-09-09

Termination date

2022-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dartford, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2920-2020