Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens f

FDA device recall Z-1984-2026 · posted 2026-04-29 · Open, Classified

Recall details

Recalling firm

Immuno-Mycologics, Inc

Reason for recall

Neutralization Buffer may contain contaminants

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PPM

Quantity affected

101 units

Distribution

US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.

Date initiated

2026-03-26

Date posted

2026-04-29

Location

Norman, OK