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Recall Observatory FDA recall evidence

Device product

ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

Z-3042-2020

August 18, 2020

Class II

Product summary

Firm
Ameditech Inc
Event
Event 86335
Status
Terminated
Classification
Class II
Quantity
51,075 units
Official record key
device-enforcement:Z-3042-2020

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

    reason.no_named_rule · v1.0.0

    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.