PlainRecalls
FDA Devices Moderate Class II Terminated

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 "

Reported: October 7, 2020 Initiated: August 18, 2020 #Z-3041-2020

Product Description

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 "

Reason for Recall

XXX

Details

Recalling Firm
Ameditech Inc
Units Affected
1,325 units
Distribution
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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 ". Recalled by Ameditech Inc. Units affected: 1,325 units.
Why was this product recalled?
XXX
Which agency issued this recall?
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3041-2020.