Z-1144-2014 Class II Terminated
FDA device recall Z-1144-2014 was initiated by Focus Diagnostics Inc on February 4, 2014 and is designated Class II. Reason for recall: Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals. The recall status is terminated (terminated November 1, 2014). Affected quantity: 2,175 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2014
- Initiation Date
- February 4, 2014
- Termination Date
- November 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,175 kits
Product Description
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
Reason for Recall
Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.
Distribution Pattern
Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
Code Information
Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.