Product Wiki · Recalls · U.S. FDA — Device Enforcement

Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 — recall Z-1344-2014

U.S. FDA — Device Enforcement · United States · 2014-03-04 · Class II

As described by U.S. FDA — Device Enforcement: Rotavirus Test Card LumiQuick, Santa Clara, CA 95054

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1344-2014
Date of alert
2014-03-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LumiQuick Diagnostics Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in the states of CA, FL, NJ, TX, and NY.
Reported risk: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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