Z-1344-2014 Class II Terminated
FDA device recall Z-1344-2014 was initiated by LumiQuick Diagnostics Inc. on March 4, 2014 and is designated Class II. Reason for recall: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. The recall status is terminated (terminated May 9, 2014). Affected quantity: ALL.
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2014
- Initiation Date
- March 4, 2014
- Termination Date
- May 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ALL
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.
Distribution Pattern
Distributed in the states of CA, FL, NJ, TX, and NY.
Code Information
Catalog number: 71029, All lots