Reported Jun 29, 2016 · Terminated

Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to…

Immuno-Mycologics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Immuno-Mycologics, Inc · 2700 Technology Pl · Norman, OK · 73071-1127

Is this the product you have?

  • Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis
  • of four specific fungal diseasesHistoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Lot codes and dates
  • Lot 111WH3
Amount recalled
467 units

Where it was sold

Why it was recalled

The device was found to have bacterial contamination.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 10, 2017 · Data as of Sep 19, 5:19 PM UTC

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