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.
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 3/5 (High).
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
- Category
- Medical Device — Diagnostic Test
- Hazard
- 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.
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