Recall Z-1344-2014— LumiQuick Diagnostics Inc.
Class II · Terminated
Class II FDA medical device recall by LumiQuick Diagnostics Inc., initiated 2014-03-04, terminated 2014-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Rotavirus Test Card LumiQuick, Santa Clara, CA 95054. Reason: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance..
- Recalling firm
- LumiQuick Diagnostics Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-04
- Terminated
- 2014-05-09
- Firm location
- Santa Clara, CA, United States
Product description
Rotavirus Test Card 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.