FDA-Device2017-02-08Class II
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Immuno-Mycologics, Inc
Hazard
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.
Sold states
Nationwide throughout the US
Affected count
630 units
Manufactured in
2700 Technology Pl, N/A, Norman, OK, United States
Products
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1109-2017Don't want to check this manually?
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