FDAJanuary 3, 2022device
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
What to do
FDA enforcement status: Terminated
Brands named
immuno mycologicsimmunoimmuno mycologics
UPCs
00816387020919
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
- 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
- FDAHistoplasma 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...2016-05-09
- FDAColostrum Powder, Dietary Supplement, Allergen statement: contains dairy. Colostrum (bovine) packaged in the following sizes and brand names: 1. PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimo...2015-11-10
- 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
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