The Recall Desk
HighFDA (Devices)·Z-0313-2016·Announced 2015-11-25

Ameditech Recalls Micro Screen 6 Panel Drug Abuse Test Cups

Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (reduced reactivity) that poses a risk of harm through inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ameditech Inc is recalling the Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU. These are one-step immunoassay tests used for the qualitative detection of multiple drugs and drug metabolites in human urine. The tests are intended for professional and point-of-care use.

The recall was initiated because the drug abuse tests have shown reduced reactivity. The affected units were distributed nationwide in the United States and internationally to Australia. The recall includes 3,574 units with the following lot codes: G140435, G140436, G150005, G150016, G150030, G150083, and G150125.

The source text does not specify specific instructions for consumers or healthcare providers regarding the disposal or return of these products.

The recalled product

Product
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of
Manufacturer
Ameditech Inc
Affected units
3,574

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)

  • G140435 G140436 G150005 G150016 G150030 G150083 G150125

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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 20 products in this recall →