Z-2040-2016 Class II Terminated
FDA device recall Z-2040-2016 was initiated by Immuno-Mycologics, Inc on May 9, 2016 and is designated Class II. Reason for recall: The device was found to have bacterial contamination. The recall status is terminated (terminated January 10, 2017). Affected quantity: 467 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2016
- Initiation Date
- May 9, 2016
- Termination Date
- January 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 467 units
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.
Distribution Pattern
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Code Information
Lot 111WH3