Reported Jun 17, 2020 · Terminated
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens,…
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 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
- Lot codes and dates
- Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
- Amount recalled
- 155 vials
Where it was sold
Why it was recalled
False positive results due to potential contamination of reagent.
This product could cause temporary or reversible health problems — stop using it.
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