FDAJuly 23, 2020device
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...
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
remel europeremel
UPCs
05056080501826
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOxoid Agglutinating Sera, Salmonella 9-0 R309573012026-03-25
- FDAYeastone Broth, 11ML, 10/BOX YY34622026-03-24
- FDACampy CVA Medium 100/PK, R012722026-02-05
- FDA1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT34502025-11-12
- FDABlood/MacConkey Biplate 100/PK, Product Number R020492025-07-11
- FDAStrep Selective II Agar, Product Number R018592025-07-11
- FDABlood Agar,5% Sheep Blood 100/PK, Product Number R012022025-07-11
- FDABlood/EMB, Levine 100/PK, Product Number R020412025-07-11
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