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

FDA device recall Z-1508-2014 · posted 2014-04-24 · Terminated

Recall details

Recalling firm

Branan Medical Corporation

Reason for recall

May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

Action taken

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

DIO

Quantity affected

9,800 units

Distribution

Worldwide Distribution: US (nationwide) and country of Canada.

Date initiated

2014-03-26

Date posted

2014-04-24

Date terminated

2014-07-23

Location

Irvine, CA

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