Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
FDA Recall #Z-1109-2017 — Class II — December 27, 2016
Product Description
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Reason for Recall
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.
Recalling Firm
Immuno-Mycologics, Inc — Norman, OK
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
630 units
Distribution
Nationwide throughout the US
Code Information
161028133653JH, 161003111544KH, and 161007105036JG
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated