Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3040-2020·Announced 2020-10-07

Ameditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures

Ameditech is recalling iCup Dx14 Drug Screen Cups because immunoassay enzymes failed performance tests, causing inconsistent detection of compounds.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.

Plain-English summary

Ameditech Inc is recalling the iCup Dx14 Drug Screen Cup, a medical device used for drug detection and adulteration testing. The recall affects 136,925 units distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. All lots within their expiry dates are included in this recall.

The recall was initiated because various immunoassay enzymes in the product failed performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This performance failure may lead to inaccurate test results.

Users of these products should stop using them and contact Ameditech Inc for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni…
Manufacturer: Ameditech Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
performance-failure
Affected units: 136,925

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

ALL Lots Within Expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 23 recalled by Ameditech Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 23 products in this recall →

Same manufacturer · Ameditech Inc

See all →

Moderate
Ameditech Noble 1 Step+ Cup Recalled for Inconsistent Performance
FDA (Devices) · 2020-10-07
Moderate
Ameditech Recalls First Check 14 Panel Drug Cups Due to Performance Failures
FDA (Devices) · 2020-10-07
High
Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures
FDA (Devices) · 2020-10-07
Moderate
Ameditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures
FDA (Devices) · 2020-10-07
Moderate
Ameditech Recalls One Step + DOA Cup Due to Performance Failures
FDA (Devices) · 2020-10-07

Same hazard · inaccurate results