Z-2311-2016Class III

AmediCheck Instant Test Cup, Part No. C-C0501A-3A

Name: Z-2311-2016 AmediCheck Instant Test Cup, Part No. C-C0501A-3A
Creator: Branan Medical Corporation
Published: 2016-07-05
License: https://open.fda.gov/license/

Branan Medical Corp. / initiated 2016-07-05 / Terminated / root cause: labeling and UDI

FDA source

Branan Medical Corporation began a recall of AmediCheck 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... on 2016-07-05. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2311-2016
Classification: Class III
Status: Terminated
Initiated: 2016-07-05
Posted: 2016-08-01
Terminated: 2016-10-04
Recalling firm: Branan Medical Corp.
Product: AmediCheck 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
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: BMC 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 [email protected]. 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 [email protected].
Quantity in commerce: 96 units
Distribution: US Nationwide distribution in the states of: TN, NC, FL, and PA
Product codes and lots: T0858

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2311-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2311-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-01

Product code DIO

K082898Class IIAmedica Drug Screen Test CupAmedica Biotech, Inc. / cleared 2008-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)