Home / Recalls / LumiQuick Diagnostics Inc. / Z-1412-2014

Z-1412-2014 Class II Terminated

Recalled by LumiQuick Diagnostics Inc. — Santa Clara, CA

Recall Details

Product Type
Devices
Report Date
April 16, 2014
Initiation Date
March 4, 2014
Termination Date
May 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
ALL

Product Description

Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Reason for Recall

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

Distribution Pattern

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

Code Information

Catalog number: 75004, All lots

Other recalls by LumiQuick Diagnostics Inc.

  • Z-1394-2014 Class II — Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1396-2014 Class II — Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1406-2014 Class II — Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1384-2014 Class II — Morphine Strip (300); LumiQuick, Santa Clara, CA 95054 (March 4, 2014)
  • Z-1386-2014 Class II — Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054 (March 4, 2014)
  • Z-1369-2014 Class II — Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1370-2014 Class II — Barbiturate Strip; LumiQuick. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1357-2014 Class II — Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1338-2014 Class II — Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054 (March 4, 2014)
  • Z-1408-2014 Class II — K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)