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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