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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 "

FDA Recall Z-3041-2020 · Posted None

Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeLDJ
Date Initiated2020-08-18
Date Terminated2024-09-30
Product Quantity1,325 units

Reason for Recall

XXX

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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