Reported Feb 8, 2017 · Terminated
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Immuno-Mycologics, 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: Immuno-Mycologics, Inc · 2700 Technology Pl · Norman, OK · 73071-1127
Is this the product you have?
- Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- Lot codes and dates
161028133653JH161003111544KHand 161007105036JG
- Amount recalled
- 630 units
Where it was sold
- Nationwide
Why it was recalled
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
This product could cause temporary or reversible health problems — stop using it.
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