Immuno-Mycologics Recalls Histoplasma Yeast Complement Fixation Antigen Due to Bacterial Contamination
Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute (Lot 111WH3) due to bacterial contamination. The product was distributed nationwide to specific states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves bacterial contamination of a medical diagnostic device. While no specific injuries or illnesses are reported in the source text, the risk of harm from using a contaminated diagnostic tool places this in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute, Reference # H30150, Lot 111WH3. The recall was initiated because the device was found to have bacterial contamination.
The product is used to detect antibodies in patient serum by the complement fixation procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis. The affected units were distributed nationwide to Utah, Massachusetts, Ohio, Indiana, North Carolina, New York, Virginia, California, Iowa, and Kentucky.
Healthcare facilities and laboratories should stop using the affected product and contact the recalling firm for instructions on return or disposal. Patients who have already received test results using this product should consult their healthcare provider if they have concerns regarding the accuracy of their diagnosis.
The recalled product
- Product
- 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 diseases: Histoplasmosis…
- Manufacturer
- Immuno-Mycologics, Inc
- Hazard
- Affected units
- 467
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 111WH3
Distribution
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