Recall Z-0270-2019 ยท NGG Test, Methamphetamine, Over The Counter
Ameditech Inc
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second ste
| Date | Sep 30, 2017 |
| Status | Terminated |
| Reason | Product was released to market without the adulteration strip included in the product. |
| Root cause | Nonconforming Material/Component |
| Action | On September 29, 2017 Ameditech Inc. send notification of the recall informing the customer to do the following: 1. If you have product in your possession: " Immediately discontinue use and/or sale of affected product lots and place in quarantine. " Complete the enclosed Customer Verification Form, within 10 days, indicating the quantity of product to be returned from your inventory. " Fax completed Customer Verification Form to 858-677-0243 or scan and e-mail to amt.fieldaction@alere.com. " Upon receipt of your Customer Verification Form, we will initiate shipment of replacement product in th |
| Quantity | 40 kit boxes (1000 units) |
| Distribution | US in the state of California |
| 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 |