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U.S. Department of Health and Human Services

Class 3 Device Recall Ameditech Accutest Drug Test Cup 5 3

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  Class 3 Device Recall Ameditech Accutest Drug Test Cup 5 3 see related information
Date Initiated by Firm September 30, 2017
Create Date October 25, 2018
Recall Status1 Terminated 3 on August 06, 2019
Recall Number Z-0270-2019
Recall Event ID 80861
510(K)Number K082898  
Product Classification Test, methamphetamine, over the counter - Product Code NGG
Product 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.
Code Information Part Number: DS84S625, Lot Number: 174886 (US distribution only)
Recalling Firm/
Manufacturer		 Ameditech Inc
9940 Mesa Rim Rd
San Diego CA 92121-2910
For Additional Information Contact
858-805-3607
Manufacturer Reason
for Recall		 Product was released to market without the adulteration strip included in the product.
FDA Determined
Cause 2		 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 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 amt.fieldaction@alere.com. 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 amt.fieldaction@alere.com.
Quantity in Commerce 40 kit boxes (1000 units)
Distribution US in the state of California
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NGG and Original Applicant = AMEDICA BIOTECH, INC.
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