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Recall Observatory FDA recall evidence

Device product

Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "

Z-3041-2020

August 18, 2020

Class II

Product summary

Firm
Ameditech Inc
Event
Event 86335
Status
Terminated
Classification
Class II
Quantity
1,325 units
Official record key
device-enforcement:Z-3041-2020

Official wording

Reason: XXX

Code information: ALL Lots Within Expiry

Distribution pattern: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX