Medical Device Control Panel Contaminated with Norovirus, Causes False Positive Results
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) negative control is contaminated with Norovirus. Users testing this control will incorrectly receive positive Norovirus results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with confirmed contamination of quality control materials. No reported illnesses or injuries in the source, but the defect compromises the function of critical quality control tools used in testing operations. Meets the rubric criterion for High severity due to risk of harm in a medical product.
Plain-English summary
Microbiologics Inc is recalling the Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. The negative control component in certain lots was contaminated with Norovirus, a pathogen that should only appear in the positive control. Users testing the negative control will obtain a false positive result for Norovirus, compromising the reliability of quality control testing.
The recall affects 580 packages distributed nationwide to 33 U.S. states and France. Affected lot numbers are 8184-65, 8184-66, 8184-67, 8184-68, 8184-69, 8184-70, and 8184-71, with expiration dates from March 31, 2025 through August 31, 2025.
Users should immediately stop using affected lots and contact Microbiologics Inc for replacement materials or further guidance.
The recalled product
- Product
- Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
- Manufacturer
- Microbiologics Inc
- Affected units
- 580
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 (13)
- Lot #8184-68
- Exp. 5/31/2025
- exp. 3/31/2025
- 8184-66
- exp. 4/30/2025
- 8184-67
- exp. 5/31/2025
- 8184-69
- exp. 6/30/2025
- 8184-70
- exp. 8/31/2025
- and 8184-71
- exp. 8/31/2025.
Distribution
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