Home / Recalls / LumiQuick Diagnostics Inc. / Z-1338-2014

Z-1338-2014 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

Syphilis Test Card Whole Blood(Serum) 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: 71016, 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-1412-2014 Class II — Cardiac Panel Test Card (Whole Blood); 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-1408-2014 Class II — K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)