Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Referenc
See all recalls from Immuno-Mycologics, Inc →Recalled Product
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 161028133653JH, 161003111544KH, and 161007105036JG
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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