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Recall Observatory FDA recall evidence

Device product

iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

Z-0506-2016

November 16, 2015

Class III

Product summary

Firm
Ameditech Inc
Event
Event 72651
Status
Terminated
Classification
Class III
Quantity
8,290 units
Official record key
device-enforcement:Z-0506-2016

Official wording

Reason: Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Code information: 141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.