FDA Medical Device Recalls (openFDA)
Immuno-Mycologics, Inc: 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
- Recall number
- Z-0545-2022
- Recalling firm
- Immuno-Mycologics, Inc
- 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
- Status
- Terminated
- Initiated
- 2022-01-03
- Posted
- not on file
- Terminated
- 2024-05-15
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- Customers who received product were contacted via letter Urgent: Medical Device Recall, Cryptococcal Antigen Lateral Flow Assay, dated January 3, 2022, beginning January 3, 2022, to locate and immediately destroy their affected devices. A recall notification and response form was attached to the email that is to be completed by the customers and returned to the firm.
- Quantity
- 411 kits
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
- Lot, serial or model codes
- F1021035 and F1021036
- 510(k) numbers
- ["K112422"]
- PMA numbers
- not on file
- Product code
- GMD
- Firm FEI
- 1627497
- Firm city
- Norman
- Firm state
- OK
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28