Recall Z-1508-2014— Branan Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Branan Medical Corporation, initiated 2014-03-26, terminated 2014-07-23. It names one FDA 510(k) clearance: K032057. 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.. Reason: May be labeled with incorrect result interpretation graphics on the ToxCup lid label..
- Recalling firm
- Branan Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-26
- Terminated
- 2014-07-23
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.