FDA (Devices) recall action 90122
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.
Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.