FDA recall Z-1419-2018

OraSure Technologies, Inc. · Class III · device

Product

Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

Reason for recall

The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

Distribution

Distributed to 2 consignees in KS.

Key facts

Status
Terminated
Initiation date
2017-12-20
Report date
2018-04-25
Termination date
2020-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1419-2018