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.
This recall has been terminated (originally issued March 30, 2018).
- Company
- Immuno-Mycologics, Inc
- Recall Initiated
- March 30, 2018
- Terminated
- May 21, 2020
- Recall Number
- Z-2409-2018
- Quantity
- 875 units
- Firm Location
- Norman, OK
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
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
Root Cause
Nonconforming Material/Component
Action Taken
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.