Recall Z-2040-2016— Immuno-Mycologics, Inc
Class II · Terminated
Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2016-05-09, terminated 2017-01-10. It names one FDA 510(k) clearance: K791393. 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, blastomycosis, coccidioidomycosis, and aspergillosis. Reason: The device was found to have bacterial contamination..
- Recalling firm
- Immuno-Mycologics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-09
- Terminated
- 2017-01-10
- Firm location
- Norman, OK, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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, blastomycosis, coccidioidomycosis, and aspergillosis
Reason for recall
The device was found to have bacterial contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.