—#183391

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 "

FDA product code: LDJ — Enzyme Immunoassay, Cannabinoids
Device class: Class 2
Medical specialty: Clinical Toxicology
Affected lot / code info: ALL Lots Within Expiry

Why it was recalled

XXX

Root cause (FDA determination)

Process control

Action the firm took

A Field Corrective Action Notice letter was sent to affected consignees. The Customer notifications commenced on 19-Aug-2020. The consignees are requested to return all non-expired product in their possession to the recalling firm. Method of Notification, 1st contact: Written field corrective action notification letters will be sent via certified mail with delivery tracking to each consignee along with a pre-paid return label to return any product remaining in stock. 2nd & 3rd contact: Telephone, follow up email, or written mail communication will be used as necessary.

Recalling firm

Firm: Ameditech Inc
Address: 9940 Mesa Rim Rd, San Diego, California 92121-2910

Distribution

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

Timeline

Recall initiated: 2020-08-18
Terminated: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.