Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 25, 2015
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ameditech Inc recalled 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests… - a moderate-severity action.
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests… was recalled by Ameditech Inc in November 25, 2015. Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.. Check the official notice for the remedy. Verify recall #Z-0302-2016 with the FDA Devices before acting.
The recall
Ameditech Inc issued this moderate-severity FDA Devices recall-Ameditech is recalling drug abuse tests because they have shown reduced reactivity..
- Moderate
- severity level
- 960 units
- affected scope
- Class II
- classification
- November 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0302-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0302-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on October 20, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Ameditech Inc is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 960 units.
The documented reason for this recall is: Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and Internationally to Australia.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
960 units
Related Recalls
6
3 from same agency
Product description
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Reason for recall
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0302-2016 |
| Date reported | November 25, 2015 |
| Date initiated | October 20, 2015 |
| Recalling firm | Ameditech Inc |
| Firm location | San Diego, CA |
| Affected scope | 960 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia. |
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-0302-2016) 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.
Frequently Asked Questions
What product was recalled? ▼
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.. Recalled by Ameditech Inc. Units affected: 960 units.
Why was this product recalled? ▼
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0302-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0302-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.