Z-1508-2014Class II

ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the...

Name: Z-1508-2014 ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the...
Creator: Branan Medical Corporation
Published: 2014-03-26
License: https://open.fda.gov/license/

Branan Medical Corp. / initiated 2014-03-26 / Terminated / root cause: labeling and UDI

FDA source

Branan Medical Corporation began a recall of 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... on 2014-03-26. FDA classified it as Class II and gives the reason as "May be labeled with incorrect result interpretation graphics on the ToxCup lid label". 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-1508-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-26
Posted: 2014-04-24
Terminated: 2014-07-23
Recalling firm: Branan Medical Corp.
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.
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Root cause tag: labeling and UDI
FDA root cause: 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: [email protected] 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 [email protected].
Quantity in commerce: 9,800 units
Distribution: Worldwide Distribution: US (nationwide) and country of Canada.
Product codes and lots: Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1508-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1508-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code DIO

K032057Class IIToxcup Drug Screen Cup Amp/coc/met/opi/pcp/thcBranan Medical Corp. / cleared 2003-08-21

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)