Class 2 Device Recall Alere iCup

• Date Initiated by Firm: August 18, 2020
• Create Date: September 30, 2020
• Recall Status: Terminated on September 30, 2024
• Recall Number: Z-3031-2020
• Recall Event ID: 86335
• 510(K)Number: K052115 K122633
• Product Classification: Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
• Product: Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
• Code Information: ALL Lots Within Expiry
• Recalling Firm/ Manufacturer: Ameditech Inc; 9940 Mesa Rim Rd; San Diego CA 92121-2910
• For Additional Information Contact: Ms. Angela Occhionero; 858-619-4969
• Manufacturer 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.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 28,525
• Distribution: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DIO; 510(K)s with Product Code = DIO