Recall Z-1144-2014— Focus Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Focus Diagnostics Inc, initiated 2014-02-04, terminated 2014-11-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Focus Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-04
- Terminated
- 2014-11-01
- Firm location
- Cypress, CA, United States
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.
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