FDAMay 9, 2016device
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, coccidioidom...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device was found to have bacterial contamination.
What to do
FDA enforcement status: Terminated
Brands named
immuno mycologicsimmunoimmuno mycologics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAImmy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis2026-03-26
- FDACandida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE2025-02-10
- FDACRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)008163870209192022-01-03
- FDAHistoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen2019-11-04
- FDACryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans...2018-03-30
- FDACryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR20032016-12-27
- FDAPerCoBa 1, Colostral Whey, Dietary Supplement, Colostral Whey Protein 6.4%. Net Contents: 4 oz. Immuno-Dynamics, Inc. , PO Box 544 Perry, Iowa 502202015-11-10
- FDAPerCoBa Whey Protein Isolate with Colostrum, Dietary Supplement. Net Weight: 1 kg (2.2 lbs), Colostrum 3,000 mg. UPC 90576-00009. Immuno-Dynamics, Inc., 18000 Dodge Street, Fennimore, WI 53809.2015-11-10
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