Z-1984-2026Class II

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

Name: Z-1984-2026 Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical...
Creator: Immuno-Mycologics, Inc
Published: 2026-03-26
License: https://open.fda.gov/license/

IMMY, Inc. / initiated 2026-03-26 / Open, Classified

FDA source

Immuno-Mycologics, Inc began a recall of Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis on 2026-03-26. FDA classified it as Class II and gives the reason as "Neutralization Buffer may contain contaminants". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1984-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-26
Posted: 2026-04-29
Recalling firm: IMMY, 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
Product code: PPM General Purpose Reagent
Reason for recall: Neutralization Buffer may contain contaminants
FDA 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: [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.
Quantity in commerce: 101 units
Distribution: US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Product codes and lots: Lot: F5061154/UDI: 00816387021091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1984-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1984-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)