Remel Europe Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2920-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 23, 2020

Date Posted: September 9, 2020

Recall Number: Z-2920-2020

Event ID: 86109

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

Status: Terminated

Product Quantity: 79 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated