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U.S. Department of Health and Human Services

Class 2 Device Recall Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test

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 Class 2 Device Recall Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID testsee related information
Date Initiated by FirmFebruary 10, 2025
Date PostedMarch 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1389-2025
Recall Event ID 96315
Product Classification Antigen, cf and / or id, coccidioides immitis - Product Code GMI
ProductCandida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Code Information Lot #: F4171005/UDI: 00816387020223
FEI Number 1627497
Recalling Firm/
Manufacturer		 Immuno-Mycologics, Inc
2701 Corporate Centre Dr
Norman OK 73069-2901
For Additional Information ContactHunter Conover
405-364-1058
Manufacturer Reason
for Recall		Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
FDA Determined
Cause 2		Process change control
ActionOn February 10, 2025, Immy issued a "Urgent Medical Device Recall" Notification to affected consignees. Immy asked consignees to take the following actions: 1. Immediately identify, count, and segregate any affected vials you have in your inventory to prevent them from being used or shipped to your customers. As soon as possible, discard your affected inventory. 2. Complete the attached Acknowledgement and Receipt Form (pages 3 and 4 below) even if you do not have any affected stock remaining in your possession. Note: The form is a fillable PDF. You can save it to your computer, fill out electronically and attach to an email. Return the completed form to IMMY using one of the methods below: o Email: customerservice@immy.com; Mail to: Attn: Hunter Conover IMMY, Inc., 2701 Corporate Centre Dr., Norman, OK USA 73069 3. Ensure relevant staff members are informed of this recall, including relevant clinicians. Clinicians should review all negative results. 4. If you have supplied any potentially affected product to another organization, please advise that organization of this recall and send them this notification. Please contact us so we can follow up with them. 5. In case product is in transit, display this letter in a prominent place for one month.
Quantity in Commerce30 vials
DistributionWorldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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