Z-0270-2019Class III

Accutest Drug Test Cup 5+3

Name: Z-0270-2019 Accutest Drug Test Cup 5+3
Creator: Ameditech Inc
Published: 2017-09-30
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2017-09-30 / Terminated / root cause: manufacturing process

FDA source

Ameditech Inc began a recall of 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... on 2017-09-30. FDA classified it as Class III and gives the reason as "Product was released to market without the adulteration strip included in the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0270-2019
Classification: Class III
Status: Terminated
Initiated: 2017-09-30
Posted: 2018-10-25
Terminated: 2019-08-06
Recalling firm: Ameditech, Inc.
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.
Product code: NGG Test, Methamphetamine, Over The Counter
Reason for recall: Product was released to market without the adulteration strip included in the product.
Root cause tag: manufacturing process
FDA 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 [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].
Quantity in commerce: 40 kit boxes (1000 units)
Distribution: US in the state of California
Product codes and lots: Part Number: DS84S625, Lot Number: 174886 (US distribution only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0270-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0270-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25

Product code NGG

K082898Class IIAmedica Drug Screen Test CupAmedica Biotech, Inc. / cleared 2008-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)