Recall Z-3034-2020 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Ameditech Inc
Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: MTD300", MF21/ "Fastect II Drug Screen Dipstick Test Single Drug Detec
| Date | Aug 18, 2020 |
| Status | Terminated |
| Reason | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Root cause | Process control |
| Action | A Field Corrective Action Notice letter was sent to affected consignees. The Customer notifications commenced on 19-Aug-2020. The consignees are requested to return all non-expired product in their possession to the recalling firm. Method of Notification, 1st contact: Written field corrective action notification letters will be sent via certified mail with delivery tracking to each consignee along with a pre-paid return label to return any product remaining in stock. 2nd & 3rd contact: Telephone, follow up email, or written mail communication will be used as necessary. |
| Quantity | 108,000 units |
| Distribution | US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain |
| FDA record | Open on fda.gov |