PlainRecalls
FDA Devices Moderate Class II Terminated

Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR30

Reported: October 7, 2020 Initiated: August 18, 2020 #Z-3030-2020

Product Description

Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10BUP-DX/ "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 10 Drug Detection: Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, and Tricyclic Antidepressant", X11-IS5 M-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS5 M-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100"

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
67,300 units
Distribution
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10BUP-DX/ "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 10 Drug Detection: Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, and Tricyclic Antidepressant", X11-IS5 M-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS5 M-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100". Recalled by Ameditech Inc. Units affected: 67,300 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-3030-2020.