Luminex Corporation is recalling 89 units of the VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test. This in vitro diagnostic test is used with the VERIGENE System to identify bacterial infections. The recall was issued because a manufacturing issue with the test cartridges could cause the system to fail to identify a bacteria or produce a false negative result. No incidents or injuries have been reported to date.
A false negative result means the test fails to detect a bacterial infection when one is actually present. This can lead to delays in life-threatening medical treatments or the administration of incorrect medications to patients with blood infections.
Firm initiated voluntary recall due to consumable issue.
For use with the sample-to-results VERIGENE System; invitro diagnostic test
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.
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Sources: FDA iRES · Raw API Response
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