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Terminated

First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B

FDA Recall Z-3049-2020 · Posted None

Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeDKZ
Date Initiated2020-08-18
Date Terminated2024-09-30
Product Quantity537,120 units

Reason for Recall

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052115FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASYFirst Check Diagnostics, LLC · 2005-12-29

Official Source

View FDA Recall →

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

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