Recall Z-2311-2016 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Branan Medical Corporation
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
| Date | Jul 5, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | BMC sent an Urgent Medical Device Recall Notice letter on July 6, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the form even if they do not have affected product. The letter informs the customers that replacement product will be provided free of charge for any unused portion of the affected lot based on completion and return of the attached Customer Verification Form. Customers are instructed to return the completed Customer Verification within 10 business days of receipt by FAX a |
| Quantity | 96 units |
| Distribution | US Nationwide distribution in the states of: TN, NC, FL, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082898 | AMEDICA DRUG SCREEN TEST CUP Amedica Biotech, Inc., Dec 19, 2008 |