medical MODERATE Updated 2017-02-08

Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Referenc

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Recalled Product

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

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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?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall