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Recall Observatory FDA recall evidence

Device product

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

Z-0514-2016

November 16, 2015

Class III

Product summary

Firm
Ameditech Inc
Event
Event 72651
Status
Terminated
Classification
Class III
Quantity
4,646 kits
Official record key
device-enforcement:Z-0514-2016

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: G140256 G140281 G140307 G140340 G140418 G140419 G150135 G150141 G150187 G150257

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.