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Recall Observatory FDA recall evidence

Device product

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

Z-1109-2017

December 27, 2016

Class II

Product summary

Firm
Immuno-Mycologics, Inc
Event
Event 76159
Status
Terminated
Classification
Class II
Quantity
630 units
Official record key
device-enforcement:Z-1109-2017

Official wording

Reason: 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.

Code information: 161028133653JH, 161003111544KH, and 161007105036JG

Distribution pattern: Nationwide throughout the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.