Recall Z-1508-2014 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Branan Medical Corporation
ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
| Date | Apr 24, 2014 (initiated Mar 26, 2014) |
| Status | Terminated |
| Reason | May be labeled with incorrect result interpretation graphics on the ToxCup lid label. |
| Root cause | Labeling Change Control |
| Action | The firm, Branan Medical Corp (BMC), sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 26, 2014 to all the customers who received the ToxCup Drug Screen Cup. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of product; quarantine all units of these product lots; destroy unused product(s) in compliance with your laboratory and state requirements; share this information with your staff and retain notification as part of your QS documentation; if distributed to your customers, provide a copy of th |
| Quantity | 9,800 units |
| Distribution | Worldwide Distribution: US (nationwide) and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC Branan Medical Corp., Aug 21, 2003 |