FDAClass IIJune 29, 2016

Histoplasma Yeast Complement Fixation Antigen Dilute recall: Contamination

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

Why was Histoplasma Yeast Complement Fixation Antigen Dilute recalled?

The device was found to have bacterial contamination.

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 111WH3

Product
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient…
Recalling firm
Immuno-Mycologics, Inc
Quantity
467 units
Distribution
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Recall date
June 29, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls