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Terminated

Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054

FDA Recall Z-1350-2014 · Posted 2014-04-07

Recalling FirmLumiQuick Diagnostics Inc.
Recall StatusTerminated
Date Initiated2014-03-04
Date Terminated2014-05-09
Product QuantityALL

Reason for Recall

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

Firm Action

Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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