LumiQuick Diagnostics Inc. recalls CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Recalled April 16, 2014 · FDA recall Z-1416-2014 · LumiQuick Diagnostics

Hazard

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. · FDA Class II

Units

ALL

Sold at

Distributed in the states of CA, FL, NJ, TX, and NY.

Description

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Product

CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Manufacturer(s)

LumiQuick Diagnostics Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →