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Recall Observatory FDA recall evidence

Device product

The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP 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. ¿¿¿

Z-0316-2016

October 20, 2015

Class II

Product summary

Firm
Ameditech Inc
Event
Event 72471
Status
Terminated
Classification
Class II
Quantity
2,240 units
Official record key
device-enforcement:Z-0316-2016

Official wording

Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Code information: G140422-C G150059-C G150063-C G150132-C

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ameditech is recalling drug abuse tests because they have shown reduced reactivity.