FDA Medical Device Recalls (openFDA)
Immuno-Mycologics, Inc: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- Recall number
- Z-1109-2017
- Recalling firm
- Immuno-Mycologics, Inc
- Product
- Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- 2017-01-27
- Terminated
- 2017-03-08
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- Immuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.
- Quantity
- 630 units
- Distribution
- Nationwide throughout the US
- Lot, serial or model codes
- 161028133653JH, 161003111544KH, and 161007105036JG
- 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