Inactivated Mycoplasma genitalium reference material recalled due to inadequate QC
Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II device recall with no reported illnesses or injuries. The hazard is a manufacturing quality control process failure affecting a reference material used in testing, which is precautionary and theoretical rather than based on confirmed harm.
Plain-English summary
Microbiologics Inc is recalling inactivated macrolide-resistant Mycoplasma genitalium reference material distributed nationwide to Nevada and Vermont. The recall was initiated because the quality control process used during manufacturing was not adequate for the specification range.
The recalled product is Catalog # HE0070N, Lot HE0070-01-1, with UDI 10845357044003. This reference material is used for quality control and testing in laboratory settings. No illnesses or injuries have been reported in association with this product.
The recalled product
- Product
- Inactivated macrolide-resistant Mycoplasma genitalium
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 2
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 (2)
- Catalog # HE0070N
- Lot HE0070-01-1 UDI: 10845357044003
Distribution
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