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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 FirmDecember 27, 2016
Date PostedJanuary 27, 2017
Recall Status1 Terminated 3 on March 08, 2017
Recall NumberZ-1109-2017
Recall Event ID 76159
510(K)NumberK112422 
Product Classification Antisera, latex agglutination, cryptococcus neoformans - Product Code GMD
ProductCryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Code Information 161028133653JH, 161003111544KH, and 161007105036JG
FEI Number 1627497
Recalling Firm/
Manufacturer		 Immuno-Mycologics, Inc
2700 Technology Pl
Norman OK 73071-1127
For Additional Information ContactJoy Pelfrey
405-364-1058
Manufacturer Reason
for Recall		The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
FDA Determined
Cause 2		Material/Component Contamination
ActionImmuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.
Quantity in Commerce630 units
DistributionNationwide throughout the US
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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