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Alere iCup Dx 14

Instant Technologies, Inc. · Model I-DX-1147-022 · UDI-DI 00817405020010

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants, CLIA Waived

Recalls

Date	Firm	Reason
2010-10-04	Express Diagnostics Int'l., Inc.	Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use o
2008-05-28	Sun Biomedical Laboratories, Inc.	Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.