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U.S. Department of Health and Human Services

Class 3 Device Recall AmediCheck Instant Test Cup

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 Class 3 Device Recall AmediCheck Instant Test Cupsee related information
Date Initiated by FirmJuly 05, 2016
Create DateAugust 01, 2016
Recall Status1 Terminated 3 on October 04, 2016
Recall NumberZ-2311-2016
Recall Event ID 74600
510(K)NumberK082898 
Product Classification Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
ProductAmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
Code Information T0858
FEI Number 3003102590
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		Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.
FDA Determined
Cause 2		Labeling mix-ups
ActionBMC sent an Urgent Medical Device Recall Notice letter on July 6, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the form even if they do not have affected product. The letter informs the customers that replacement product will be provided free of charge for any unused portion of the affected lot based on completion and return of the attached Customer Verification Form. Customers are instructed to return the completed Customer Verification within 10 business days of receipt by FAX at 949-598-7166, or by email at branan.complaints@brananmedical.com. Customers with any questions about the information contained in the notification are instructed to contact Branan Medical Corporation at 949-598-7166 or by e-mail at branan.complaints@brananmedical.com.
Quantity in Commerce96 units
DistributionUS Nationwide distribution in the states of: TN, NC, FL, and PA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DIO
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