Recall Z-3040-2020 ยท LDJ Enzyme Immunoassay, Cannabinoids
Ameditech Inc
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH, Bl, S.G.", X11-I-DX-1147-022 /"iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO30
| 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 | 136,925 units |
| Distribution | US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122633 | TOXCUP DRUG SCREEN CUP Branan Medical Corp., Feb 7, 2013 |