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.
FDA Recall Z-1508-2014 · Posted 2014-04-24
Recalling FirmBranan Medical Corporation
Recall StatusTerminated
Product CodeDIO
Date Initiated2014-03-26
Date Terminated2014-07-23
Product Quantity9,800 units
Reason for Recall
May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Firm 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].
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.