OraSure Technologies, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1419-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: December 20, 2017

Date Posted: April 25, 2018

Recall Number: Z-1419-2018

Event ID: 79534

Reason for Recall:

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

Status: Terminated

Product Quantity: 10

Code Information:

Lot Number: 0006661251, Expiration date: 02/28/2018

Distribution Pattern:

Distributed to 2 consignees in KS.

Voluntary or Mandated:

Voluntary: Firm initiated