Device product
QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+ MDMA500+BUP10", QT11 / "QuickTox¿ Drug Screen Dipcard 5 Drug Detection: COC300+OPI2000+THC50+AMP1000+PCP25", QT52/ "QuickTox¿ Drug Screen Dipcard 9 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+MTD300+OXY100", QT44/ "QuickTox¿ Drug Screen Dipcard 8 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+OXY100", QT23/ "QuickTox¿ Drug Screen Dipcard 6 Drug Detection: COC300+OPI2000+MET500+THC50+AMP1000+PCP25", QT80F/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+TCA1000+OXY100+MDMA500 with Positive Control Line", QT52A/ "QuickTox¿ Drug Screen Dipcard 9 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+MTD300+OXY100 4 Adulteration Test: Cr, Ni, pH, Ox ", QT20/ "QuickTox" Drug Screen Dipcard 5 Drug Detection: COC300+OPI2000+MET500+THC50+AMP1000"
Z-3043-2020
Product summary
- Firm
- Ameditech Inc
- Event
- Event 86335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170,425 units
- Official record key
device-enforcement:Z-3043-2020
Official wording
Reason: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Code information: ALL Lots Within Expiry
Distribution pattern: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Derived failure modes
-
Unknown
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.