Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model #

Hazard / Issue

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

Issued by

FDA

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/Code Info: Lot/Serial Numbers: L102802 and L103012