Ortho-Clinical Diagnostics, Inc. is recalling 952 Solana Bordetella Complete Assay kits (Model M308) due to a technical defect. It was determined that certain lots of the assay can produce false positive results for Bordetella parapertussis (BPP) at a rate as high as 16.7%. These kits, which contain materials for 48 tests each, are used in laboratory settings to detect respiratory infections, and no injuries or incidents have been reported to date.
A false positive result means a patient could be incorrectly diagnosed with a Bordetella parapertussis infection they do not have. This could lead to unnecessary medical treatments, inappropriate antibiotic use, or required isolation protocols for the patient.
One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Until further notice, all future lots will be affected.
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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