Immuno-mycologics, Inc: General Purpose Reagent
Recall Summary Immuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B (a reagent used to process clinical samples for tuberculosis testing) because the buffer may contain contaminants. This Class I recall affects the product distributed nationwide, and laboratories using this reagent for mycobacterium testing may be impacted.
- 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
- Reason
- Neutralization Buffer may contain contaminants
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/603a36a2-7a90-4429-bb2f-1b9f15fa65d7