Device 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.
Z-1508-2014
Product summary
- Event
- Event 67818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,800 units
- Official record key
device-enforcement:Z-1508-2014
Official wording
Reason: May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Code information: Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
Distribution pattern: Worldwide Distribution: US (nationwide) and country of Canada.
Derived failure modes
-
Unknown
May be labeled with incorrect result interpretation graphics on the ToxCup lid label.