Remel Bordetella pertussis Agglutinating Serum Recalled for False Negative Results
Remel Europe Ltd. is recalling Thermo Scientific Remel Bordetella pertussis Agglutinating Serum because it may produce false negative results for serotypes 1 and 3.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic medical device that may produce false negative results, posing a risk of harm through misdiagnosis, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Remel Europe Ltd. is recalling 79 units of Thermo Scientific Remel Bordetella pertussis Agglutinating Serum, Product Number R30165501, UDI-DI 05056080501826, Lot # 2407976. The product is used in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.
The recall was initiated because the product is not performing as intended, resulting in the potential for false negative results for serotypes 1 and 3. This defect may lead to incorrect diagnostic conclusions regarding the presence of these specific Bordetella serotypes.
The affected units were distributed worldwide, including nationwide distribution in the United States and in the states of Missouri and California, as well as in the countries of Canada, Austria, Bolivia, China, Czechia, United Kingdom, Gambia, Hong Kong, Ireland, Italy, Mexico, Malaysia, Netherlands, Oman, and Saudi Arabia. Users of this product should stop using the recalled lot and contact Remel Europe Ltd. for further instructions or replacement.
The recalled product
- 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…
- Manufacturer
- Remel Europe Ltd.
- Affected units
- 79
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 2407976
Distribution
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