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U.S. Department of Health and Human Services

Class 2 Device Recall Alere iCup

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  Class 2 Device Recall Alere iCup see related information
Date Initiated by Firm August 18, 2020
Create Date September 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-3031-2020
Recall Event ID 86335
510(K)Number K122633  K052115  
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 2		 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DIO and Original Applicant = BRANAN MEDICAL CORP.
510(K)s with Product Code = DIO and Original Applicant = FIRST CHECK DIAGNOSTICS LLC
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