medical MODERATE Updated 2020-06-17

Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling i

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Recalled Product

Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

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Hazard / Issue

False positive results due to potential contamination of reagent.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909

✅ 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