Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported September 6, 2017
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labele…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ameditech Inc recalled Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 indiv… - a low-severity action.
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 indiv… was recalled by Ameditech Inc in September 6, 2017. Reason: The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the …. Check the official notice for the remedy. Verify recall #Z-3084-2017 with the FDA Devices before acting.
The recall
Ameditech Inc issued this low-severity FDA Devices recall-The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the ….
- Low
- severity level
- Class III
- classification
- September 6, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3084-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3084-2017) was formally reported on September 6, 2017, with the manufacturer initiating the action on June 26, 2017. It is classified under Low severity (Class III), 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 263Kits.
The documented reason for this recall is: The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly. Distribution data in the federal record shows the product reached: Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
263Kits
Related Recalls
6
3 from same agency
Product description
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
Reason for recall
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-3084-2017 |
| Date reported | September 6, 2017 |
| Date initiated | June 26, 2017 |
| Recalling firm | Ameditech Inc |
| Firm location | San Diego, CA |
| Affected scope | 263Kits |
| Distribution | Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX |
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-3084-2017) 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? ▼
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine. Recalled by Ameditech Inc. Units affected: 263Kits.
Why was this product recalled? ▼
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Low. Recall number: Z-3084-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3084-2017) 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 September 6, 2017. 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.