Home / Recalls / LumiQuick Diagnostics Inc. / Z-1342-2014

Z-1342-2014 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

H. Pylori Antibody 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: 71024, All lots

Other recalls by LumiQuick Diagnostics Inc.

  • Z-1392-2014 Class II — Ketamine Strip; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1401-2014 Class II — Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1359-2014 Class II — Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1366-2014 Class II — Tramadol Strip; LumiQuick. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1343-2014 Class II — Salmonella typhi Antigen 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-1344-2014 Class II — Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 (March 4, 2014)
  • Z-1416-2014 Class II — CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1376-2014 Class II — EDDP Strip; LumiQuick. Santa Clara, CA 95054 (March 4, 2014)
  • Z-1402-2014 Class II — Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054 (March 4, 2014)