Reported Sep 9, 2020 · Terminated

Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 -…

Remel Europe Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Remel Europe Ltd. · Clipper Boulevard West · Dartford, N/A · N/A

Is this the product you have?

  • Thermo Scientific Remel Bordetella pertussis
  • Agglutinating Serum Product NumberR30165501
  • UDI-DI05056080501826 -
  • Product UsageBordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes
Lot codes and dates
  • Lot # 2407976
Amount recalled
79 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 22, 2022 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.