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U.S. Department of Health and Human Services

Class 2 Device Recall Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)

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  Class 2 Device Recall Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) see related information
Date Initiated by Firm March 30, 2018
Create Date July 10, 2018
Recall Status1 Open3, Classified
Recall Number Z-2409-2018
Recall Event ID 80284
510(K)Number K112422  
Product Classification Antisera, latex agglutination, cryptococcus neoformans - Product Code GMD
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.
Code Information Lot/Serial Numbers: L102802 and L103012
Recalling Firm/
Manufacturer
Immuno-Mycologics, Inc
2700 Technology Pl
Norman OK 73071-1127
For Additional Information Contact Qualtiy Assurance Dept
405-360-4669
Manufacturer Reason
for Recall
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GMD and Original Applicant = IMMUNO-MYCOLOGICS, INC.
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