Device product
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."
Z-3039-2020
Product summary
- Firm
- Ameditech Inc
- Event
- Event 86335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,700 units
- Official record key
device-enforcement:Z-3039-2020
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.