Branan Medical Corporation recalls AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnos…

Recall date

July 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2311-2016

FDA classification

Class III

Brand / firm

Branan Medical Corporation

Sold / distributed

US Nationwide distribution in the states of: TN, NC, FL, and PA

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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 Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA