Candida ID Antigen recalled for reduced sensitivity, potential false negatives
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
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: This is a risk-of-harm product where false negative diagnostic results could lead to missed Candida diagnoses and delayed patient treatment. While no illnesses have been reported, the potential for patient harm is significant due to the nature of the defect.
Plain-English summary
Immuno-Mycologics, Inc is recalling Candida ID Antigen (Lot F4171005) because the reagent may have reduced sensitivity. This reduced sensitivity could result in false negative test results, meaning patients with Candida infections might test negative when they should test positive.
The affected product (30 vials, UDI 00816387020223) has been distributed worldwide, including in the United States (California and Oklahoma) and internationally (Peru, France, Austria, and Venezuela).
Healthcare facilities and laboratories using this lot should stop use and contact the manufacturer for a replacement. Any patient testing performed with the affected lot should be reviewed by medical professionals. Healthcare providers should be notified of this recall to ensure patients with potential Candida infections receive appropriate follow-up testing and care.
The recalled product
- Product
- Candida 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, CE
- Manufacturer
- Immuno-Mycologics, Inc
- Hazard
- false-negative-results
- reduced-sensitivity
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)
- Lot #: F4171005/UDI: 00816387020223
Distribution
Distributed nationwide across the United States.
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