FDA Medical Device Recalls (openFDA)
Immuno-Mycologics, Inc: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
- Recall number
- Z-1984-2026
- Recalling firm
- Immuno-Mycologics, Inc
- Product
- Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
- Status
- Open, Classified
- Initiated
- 2026-03-26
- Posted
- 2026-04-29
- Terminated
- not on file
- Reason
- Neutralization Buffer may contain contaminants
- Root cause
- Under Investigation by firm
- Action
- On 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
- 101 units
- Distribution
- US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
- Lot, serial or model codes
- Lot: F5061154/UDI: 00816387021091
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 1627497
- Firm city
- Norman
- Firm state
- OK
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28