CLASS III Device recall · Reported 6 Sep 2017 · FDA Enforcement Report
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection recalled
Ameditech is recalling Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26, distributed nationwide in the US. The recall was initiated on 26 Jun 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-3084-2017
- FDA event ID
- 77702
- Recalling firm
- Ameditech, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Jun 2017
- FDA classified
- 29 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Jun 2017 | Recall initiated by company | |
| 29 Aug 2017 | Classified by FDA | +64 days |
| 6 Sep 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Nationwide ArizonaIllinoisIndianaKentuckyNevadaPennsylvaniaTennesseeTexas
Questions about this recall
Why was it 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 lots are affected?
P/N IS10-DX; Lot No. U0731
Where was it sold?
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
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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