Remel Europe Ltd. is recalling 117 units of Oxoid Agglutinating Sera, Salmonella 9-0 used in laboratory testing. The affected product lots may fail to perform correctly, showing a cross-reaction within 60 seconds that could lead to the misidentification of a Salmonella 9-O serotype as a 2-O serotype. This recall affects 16 specific lots distributed across 15 U.S. states and worldwide. No incidents or injuries have been reported to date.
The laboratory diagnostic sera may show a false-positive cross-reaction, which can cause laboratory professionals to misidentify the specific strain of Salmonella being tested. This misidentification could potentially lead to incorrect medical or epidemiological data.
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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