PlainRecalls
FDA Devices Moderate Class II Terminated

Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150)+(OPI300/MET500)+ (AMP500/BZO300)+(BAR300/MTD300)+ (BOPG10/TCA1000)+(MDMA500/OXY100)+ (PCP25/PPX300) w/ Cr, Ni, pH, Bl, S.G."

Reported: October 7, 2020 Initiated: August 18, 2020 #Z-3039-2020

Product Description

Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150)+(OPI300/MET500)+ (AMP500/BZO300)+(BAR300/MTD300)+ (BOPG10/TCA1000)+(MDMA500/OXY100)+ (PCP25/PPX300) w/ Cr, Ni, pH, Bl, S.G."

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
13,700 units
Distribution
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150)+(OPI300/MET500)+ (AMP500/BZO300)+(BAR300/MTD300)+ (BOPG10/TCA1000)+(MDMA500/OXY100)+ (PCP25/PPX300) w/ Cr, Ni, pH, Bl, S.G.". Recalled by Ameditech Inc. Units affected: 13,700 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-3039-2020.

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