Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL)see related information
Date Initiated by FirmMarch 26, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1984-2026
Recall Event ID 98702
Product Classification General purpose reagent - Product Code PPM
ProductImmy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Code Information Lot: F5061154/UDI: 00816387021091
FEI Number 1627497
Recalling Firm/
Manufacturer		 Immuno-Mycologics, Inc
2701 Corporate Centre Dr
Norman OK 73069-2901
For Additional Information ContactIMMY's Customer service
405-364-1058
Manufacturer Reason
for Recall		Neutralization Buffer may contain contaminants
FDA Determined
Cause 2		Under Investigation by firm
ActionOn March 25, 2025 Immuno-Mycologics, Inc (IMMY) issued a Urgent Medical Device Recall Notification via E-Mail. IMMY ask consignees to take the following actions: 1. Immediately identify, count, and segregate any kits from this lot you have in your inventory to prevent them from being used or shipped to your customers. 2. As soon as possible, discard your affected inventory. 3. Complete the attached Acknowledgement and Receipt Form even if you do not have any affected stock remaining in your possession. Return the completed form to IMMY using one of the methods below: - Email: customerservice@immy.com, Mail to: Recall #: 1627497-2026-001, 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 patient test 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 Commerce101 units
DistributionUS Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
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.
-
-