Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination
Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall. The product is used in clinical laboratory diagnosis, and contamination in a neutralization buffer used for specimen processing poses a risk of incorrect test results that could affect patient diagnosis and treatment decisions.
Plain-English summary
Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, REF: TBPN67-60, Lot: F5061154/UDI: 00816387021091) due to the potential presence of contaminants in the product.
This neutralization buffer is used for processing of clinical specimens for Mycobacterium spp. diagnosis. A total of 101 units have been distributed nationwide across Arizona, Mississippi, South Carolina, Connecticut, North Carolina, Texas, Indiana, Washington, Missouri, Michigan, and California.
Healthcare facilities and laboratories that have received this product should discontinue use and contact Immuno-Mycologics, Inc. for instructions on return or replacement of affected units. The FDA classified this as a Class II recall.
The recalled product
- 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
- Manufacturer
- Immuno-Mycologics, Inc
- Affected units
- 101
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: F5061154/UDI: 00816387021091
Distribution
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