Recall Z-0270-2019— Ameditech Inc
Class III · Terminated
Class III FDA medical device recall by Ameditech Inc, initiated 2017-09-30, terminated 2019-08-06. It names one FDA 510(k) clearance: K082898. 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.. Reason: Product was released to market without the adulteration strip included in the product..
- Recalling firm
- Ameditech Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-09-30
- Terminated
- 2019-08-06
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
Product was released to market without the adulteration strip included in the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.