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Class 2 Device Recall ImmuTest |
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Date Initiated by Firm |
August 18, 2020 |
Create Date |
September 30, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-3036-2020 |
Recall Event ID |
86335 |
510(K)Number |
K052115 K113046
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Product Classification |
Alcohol control materials - Product Code DKC
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Product |
ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description):
IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.",
IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION",
IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."
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Code Information |
ALL Lots Within Expiry |
Recalling Firm/ Manufacturer |
Ameditech Inc 9940 Mesa Rim Rd San Diego CA 92121-2910
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For Additional Information Contact |
Ms. Angela Occhionero 858-619-4969
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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.
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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 |
27,375 units |
Distribution |
US - Nationwide
OUS - Australia, France, Germany, New Zealand, Singapore and Spain |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DKC and Original Applicant = AMEDITECH, INC. 510(K)s with Product Code = DKC and Original Applicant = FIRST CHECK DIAGNOSTICS LLC
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