Ameditech Inc: Medical Device Recall in 2020 - (Recall #: Z-3043-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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"
Class II
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.
ALL Lots Within Expiry
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Voluntary: Firm initiated