Immuno-Mycologics, Inc: 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.

Recall number

Z-2409-2018

Recalling firm

Immuno-Mycologics, Inc

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.

Status

Terminated

Initiated

2018-03-30

Posted

not on file

Terminated

2020-05-21

Reason

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

Root cause

Nonconforming Material/Component

Action

On March 30, 2018, IMMY issued URGENT MEDICAL DEVICE RECALL notices to their customers via email. The notice instructed customers how to identify a device which may fail. 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 attached Acknowledgement and Receipt Form even if you do not have any affected stock remaining and return via email to: customerservice@immy.com. Before contacting customer service, please have the following information available: approval to receive a no charge replacement and/or a no-charge PO and the shipping information, including an attention line.

Quantity

875 units

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 letter in a prominent place for one month. Should you need a replacement kit, you will need to return your affected inventory. Instructions will be provided by customer service on how to return kits to IMMY. If you have any questions, contact IMMYs Quality Assurance Department by calling 1-405-360-4669 Monday through Friday 8:30 AM to 5:00 PM Central Standard Time.

Lot, serial or model codes

Lot/Serial Numbers: L102802 and L103012

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

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

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