The Recall Desk
HighFDA (Devices)·Z-0545-2022·Announced 2022-02-09

Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity

Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with reduced diagnostic accuracy (90% vs. 99% specificity), classified as FDA Class II. While no illnesses or injuries have been reported, the reduced specificity poses a risk of false-positive results that could lead patients to initiate unnecessary anti-fungal therapy.

Plain-English summary

Immuno-Mycologics, Inc. is recalling 411 Cryptococcal Antigen Lateral Flow Assay test kits (REF CR2003, lot codes F1021035 and F1021036) distributed nationwide. The test kits are used to detect cryptococcal antigen in blood serum and cerebrospinal fluid samples.

The recall is due to reduced specificity. The affected kits now have 90% specificity, compared to the previous 99% specification. As a result, some samples with positive test results may be false positives, incorrectly indicating the presence of cryptococcal antigen.

False-positive test results could cause patients to initiate unnecessary anti-fungal therapy. Negative test results from the affected kits are not affected by this issue. Healthcare providers using these test kits should be aware of the reduced specificity when interpreting results from the affected lot codes.

The recalled product

Product
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
Manufacturer
Immuno-Mycologics, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
  • false-positive
  • test-accuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • F1021035 and F1021036

Distribution

Distributed nationwide across the United States.

Related recalls

Same category