FDA Devices recall · Reported October 31, 2018
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 was released to market without the adulteration strip included in the product.
Ameditech Inc recalled Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro d… - a low-severity action.
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro d… was recalled by Ameditech Inc in October 31, 2018. Reason: Product was released to market without the adulteration strip included in the product.. Check the official notice for the remedy. Verify recall #Z-0270-2019 with the FDA Devices before acting.
The recall
Ameditech Inc issued this low-severity FDA Devices recall-Product was released to market without the adulteration strip included in the product..
- Low
- severity level
- Class III
- classification
- October 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0270-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0270-2019 |
| Date reported | October 31, 2018 |
| Date initiated | September 30, 2017 |
| Recalling firm | Ameditech Inc |
| Firm location | San Diego, CA |
| Affected scope | 40 kit boxes (1000 units) |
| Distribution | US in the state of California |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0270-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026