—#166754

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.

FDA product code: NGG — Test, Methamphetamine, Over The Counter
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K082898
Affected lot / code info: Part Number: DS84S625, Lot Number: 174886 (US distribution only)

Why it was recalled

Product was released to market without the adulteration strip included in the product.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Ameditech Inc
Address: 9940 Mesa Rim Rd, San Diego, California 92121-2910

Distribution

Distribution pattern: US in the state of California

Timeline

Recall initiated: 2017-09-30
Terminated: 2019-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166754. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.