Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
FDA device recall Z-1404-2014 · posted 2014-04-07 · Terminated
Recall details
- Recalling firm
- LumiQuick Diagnostics Inc.
- Reason for recall
- Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- ALL
- Distribution
- Distributed in the states of CA, FL, NJ, TX, and NY.
- Date initiated
- 2014-03-04
- Date posted
- 2014-04-07
- Date terminated
- 2014-05-09
- Location
- Santa Clara, CA
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