Reported Mar 12, 2014 · Terminated
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A,…
Focus Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Focus Diagnostics Inc · 11331 Valley View St · Cypress, CA · 90630-5366
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number MOL2650
- Lot Numbers
244932449524535245362459124603246052473224773247882479724807
- Amount recalled
- 2,175 kits
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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