Recall Z-1416-2014— 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: CK-MB Test Card (Whole Blood); 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
CK-MB 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.