PlainRecalls
FDA Devices Moderate Class II Terminated

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: COC30

Reported: October 7, 2020 Initiated: August 18, 2020 #Z-3043-2020

Product Description

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"

Reason for Recall

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.

Details

Recalling Firm
Ameditech Inc
Units Affected
170,425 units
Distribution
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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". Recalled by Ameditech Inc. Units affected: 170,425 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3043-2020.