Histoplasma Immunodiffusion recall: Contamination
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID…
Why was Histoplasma Immunodiffusion recalled?
False positive results due to potential contamination of reagent.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
- Product
- Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID…
- Recalling firm
- Immuno-Mycologics, Inc
- Quantity
- 155 vials
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)