# FDA recall Z-2409-2018

> **Immuno-Mycologics, Inc** · Class II · device recall initiated 2018-03-30.

## Product

Cryptococcal 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 and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF).  The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

## Reason for recall

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

## Distribution

On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email.  Customers were advised on how to recognize that the device has failed.      The following are Actions to be taken by the customer/user:  " You may continue using the affected lots. Any testing performed on defective strips should be considered invalid and should be repeated.  " Please immediately notify lab personnel who are running the test to look for defective strips (as seen by fast wicking and/or very weak control lines).  " Please immediately complete the Acknowledgement and Receipt Form even if you do not have any affected stock remaining and submit via email to: customerservice@immy.com.    " Ensure relevant staff members are informed of this recall, including relevant clinicians.  " If you have supplied any potentially affected product to another organization, please advise that organization of this recall and notify IMMY.    " In case product is in transit, display this lette

## Key facts

- **Recall number:** Z-2409-2018
- **Recalling firm:** Immuno-Mycologics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-30
- **Report date:** 2018-07-18
- **Termination date:** 2020-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norman, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2018

## Citation

> AI Analytics. FDA recall Z-2409-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2409-2018. Source: US FDA. Licensed CC0.

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