Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X… recallZ-1984-2026 · Immuno-Mycologics, Inc · initiated Mar 26, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Immuno-Mycologics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Neutralization Buffer may contain contaminants
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected], 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.
Recall details
- Recall number
- Z-1984-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 26, 2026
- Posted by the FDA
- Apr 29, 2026
- Recalling firm
- Immuno-Mycologics, Inc
- Quantity
- 101 units
- Product code
- PPM
- Distribution
- US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Product description
Immy, 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 (models, lots, serial numbers)
Lot: F5061154/UDI: 00816387021091
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IMMY TBPN67Immuno-Mycologics, Inc. · General Purpose Reagent1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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