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U.S. Department of Health and Human Services

Class 2 Device Recall ToxCup Drug Screen Cup

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  Class 2 Device Recall ToxCup Drug Screen Cup see related information
Date Initiated by Firm March 26, 2014
Date Posted April 24, 2014
Recall Status1 Terminated 3 on July 23, 2014
Recall Number Z-1508-2014
Recall Event ID 67818
510(K)Number K032057  
Product Classification Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
Product ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
Code Information Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
Recalling Firm/
Manufacturer		 Branan Medical Corporation
140 Technology Dr Ste 400
Irvine CA 92618-2426
For Additional Information Contact
949-598-7166
Manufacturer Reason
for Recall		 May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
FDA Determined
Cause 2		 Labeling Change Control
Action The firm, Branan Medical Corp (BMC), sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 26, 2014 to all the customers who received the ToxCup Drug Screen Cup. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of product; quarantine all units of these product lots; destroy unused product(s) in compliance with your laboratory and state requirements; share this information with your staff and retain notification as part of your QS documentation; if distributed to your customers, provide a copy of this letter to them; complete and return the enclosed Customer Verification Form via Fax to: Branan Medical Corporation at 949-598-7167 or by e-mail at: branan.complaints@brananmedical.com within 10 days. Should you have any questions about the information contained in this notification, contact Branan Medical Corporation at (949) 598-7166 or email branan.complaints@brananmedical.com.
Quantity in Commerce 9,800 units
Distribution Worldwide Distribution: US (nationwide) and country of Canada.
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 and Original Applicant = BRANAN MEDICAL CORP.
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