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
FDA Recall Z-2040-2016 · Posted 2016-06-20
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Recalling FirmImmuno-Mycologics, Inc
Recall StatusTerminated
Product CodeGMJ
Date Initiated2016-05-09
Date Terminated2017-01-10
Product Quantity467 units
Reason for Recall
The device was found to have bacterial contamination.
Firm Action
Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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