Immuno-Mycologics Recalls

5 recalls on record in the United States

medical: 5
medical Class II
2017-02-08

Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Referenc

The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

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medical Class II
2025-03-26

Immuno-Mycologics, Inc recalls Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

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medical Class II
2022-02-09

Immuno-Mycologics, Inc recalls CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow

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.

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medical Class II
2020-06-17

Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling i

False positive results due to potential contamination of reagent.

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medical Class II
2018-07-18

Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model #

Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results

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