FDA-Device2015-11-25Class II
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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 drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Ameditech Inc
Hazard
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Affected count
300 units
Manufactured in
9940 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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 drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2016Don't want to check this manually?
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