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[Recalled] 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 B

recall fda device united-kingdom

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductThermo 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 an
Brand / manufacturerRemel Europe Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2920-2020
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date23 July 2020
EAN / barcode05056080501826

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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