Z-1984-2026 Class II Ongoing
FDA device recall Z-1984-2026 was initiated by Immuno-Mycologics, Inc on March 26, 2026 and is designated Class II. Reason for recall: Neutralization Buffer may contain contaminants The recall status is ongoing. Affected quantity: 101 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- March 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101 units
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
Reason for Recall
Neutralization Buffer may contain contaminants
Distribution Pattern
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Code Information
Lot: F5061154/UDI: 00816387021091