FDAJuly 5, 2016device
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetam...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.
What to do
FDA enforcement status: Terminated
Brands named
branan medicalbranan
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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