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U.S. Department of Health and Human Services

Class 2 Device Recall CrAg Lateral Flow Assay

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 Class 2 Device Recall CrAg Lateral Flow Assaysee related information
Date Initiated by FirmJanuary 03, 2022
Create DateJanuary 31, 2022
Recall Status1 Terminated 3 on May 15, 2024
Recall NumberZ-0545-2022
Recall Event ID 89370
510(K)NumberK112422 
Product Classification Antisera, latex agglutination, cryptococcus neoformans - Product Code GMD
ProductCRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
Code Information F1021035 and F1021036
Recalling Firm/
Manufacturer		 Immuno-Mycologics, Inc
2701 Corporate Centre Dr
Norman OK 73069-2901
For Additional Information ContactJoy Pelfrey
405-364-1058
Manufacturer Reason
for Recall		The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
FDA Determined
Cause 2		Material/Component Contamination
ActionCustomers who received product were contacted via letter Urgent: Medical Device Recall, Cryptococcal Antigen Lateral Flow Assay, dated January 3, 2022, beginning January 3, 2022, to locate and immediately destroy their affected devices. A recall notification and response form was attached to the email that is to be completed by the customers and returned to the firm.
Quantity in Commerce411 kits
DistributionUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GMD
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