AlereTM iScreenRecalls & reported problems across all models
Instant Technologies, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one AlereTM iScreen model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of AlereTM iScreen by Instant Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 30, 2017 and Oct 30, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
AlereTM iScreen recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1589-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported AlereTM iScreen problems
Device problems
- False Positive Result1
Patient problems
- No Consequences Or Impact To Patient1
AlereTM iScreen models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AlereTM iScreen® IS5MRadioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- AlereTM iScreen® IS9Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
Recent AlereTM iScreen adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2017False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING ONE FALSE POSITIVE THC RESULT AND ONE FALSE POSITIVE COC RESULT ON ONE PATIENT USING THE ALERE ISCREEN 9 PANEL TEST. CONFIRMATORY TESTING WAS CONDUCTED AND PRODUCED NEGATIVE RESULTS FOR BOTH DRUGS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6989010 ↗
Other Instant Technologies, Inc. products
All Instant Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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