CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
ToxCup Drug Screen Cup recalled by Branan Medical
Branan Medical is recalling ToxCup Drug Screen Cup, distributed nationwide in the US. The recall was initiated on 26 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1508-2014
- FDA event ID
- 67818
- Recalling firm
- Branan Medical, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2014
- FDA classified
- 24 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Mar 2014 | Recall initiated by company | |
| 24 Apr 2014 | Classified by FDA | +29 days |
| 30 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and country of Canada.
Questions about this recall
Why was it recalled?
May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Which lots are affected?
Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
Where was it sold?
Worldwide Distribution: US (nationwide) and country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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