CLASS III Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
Accutest Drug Test Cup 5+3 recalled by Ameditech
Ameditech is recalling Accutest Drug Test Cup 5+3, distributed in California. The recall was initiated on 30 Sep 2017 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0270-2019
- FDA event ID
- 80861
- Recalling firm
- Ameditech, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Sep 2017
- FDA classified
- 25 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Sep 2017 | Recall initiated by company | |
| 25 Oct 2018 | Classified by FDA | +390 days |
| 31 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was released to market without the adulteration strip included in the product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US in the state of California
Questions about this recall
Why was it recalled?
Product was released to market without the adulteration strip included in the product.
Which lots are affected?
Part Number: DS84S625, Lot Number: 174886 (US distribution only)
Where was it sold?
US in the state of California
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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