Z-1508-2014 Class II Terminated
FDA device recall Z-1508-2014 was initiated by Branan Medical Corporation on March 26, 2014 and is designated Class II. Reason for recall: May be labeled with incorrect result interpretation graphics on the ToxCup lid label. The recall status is terminated (terminated July 23, 2014). Affected quantity: 9,800 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2014
- Initiation Date
- March 26, 2014
- Termination Date
- July 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,800 units
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of Canada.
Code Information
Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079