LumiQuick Diagnostics Inc.: Medical Device Recall in 2014 - (Recall #: Z-1352-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054

Product Classification:

Class II

Date Initiated: March 4, 2014

Date Posted: April 16, 2014

Recall Number: Z-1352-2014

Event ID: 67665

Reason for Recall:

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

Status: Terminated

Product Quantity: ALL

Code Information:

Catalog number: 71053, All lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated