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 step in the process-is provided in the package labeling.
Recall
- Recall Number
- Z-0270-2019
- Event Number
- 80861
- Firm
- Ameditech Inc
- FEI Number
- 3003789989
- Product Code
- NGG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 30, 2017
- Terminated
- August 6, 2019
- Address
- 9940 Mesa Rim Rd, San Diego, CA, 92121-2910
Description
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 step in the process-is provided in the package labeling.
Product was released to market without the adulteration strip included in the product.
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 [email protected]. " Upon receipt of your Customer Verification Form, we will initiate shipment of replacement product in the quantity indicated on the form and contact you to arrange product return. " Return product as directed. 2. If you have no remaining product in your possession: " Complete the enclosed Customer Verification Form, within 10 days, indicating "We do not have any affected product." " Fax completed Customer Verification Form to 858-677-0243 or scan and e-mail to [email protected]. 3. Share this information with your staff and retain this notification as part of your records. Please complete this form and return within 10 business days even if you do not have any remaining product. Send form to Ameditech at Fax Number 858-677-0243 or by e-mail at [email protected].
US in the state of California
40 kit boxes (1000 units)