Recall Z-3049-2020 ยท DKZ Enzyme Immunoassay, Amphetamine
Ameditech Inc
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
| 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 | 537,120 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
| K052115 | FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY First Check Diagnostics, LLC, Dec 29, 2005 |