FDA Medical Device Recalls (openFDA)
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 step in the process-is provided in the package labeling.
- Recall number
- Z-0270-2019
- 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.
- Status
- Terminated
- Initiated
- 2017-09-30
- Posted
- not on file
- Terminated
- 2019-08-06
- 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 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
- 40 kit boxes (1000 units)
- Distribution
- US in the state of California
- Lot, serial or model codes
- Part Number: DS84S625, Lot Number: 174886 (US distribution only)
- 510(k) numbers
- ["K082898"]
- PMA numbers
- not on file
- Product code
- NGG
- Firm FEI
- 3003789989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28