Medical Device Reference Standard Recalled for Inadequate Quality Control Process
Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.
What this means for you
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: FDA Class II classification with no reported illnesses, injuries, or deaths. The hazard is a quality control and specification compliance issue rather than an active safety hazard, consistent with the rubric category of low-risk quality defects.
Plain-English summary
Microbiologics Inc is recalling inactivated macrolide and quinolone-resistant Mycoplasma genitalium reference standard (Catalog HE0069N, Lot HE0069-02-1) due to quality control deficiencies. This reference standard is used by diagnostic and clinical laboratories as a quality control material for testing and verification purposes.
The manufacturer determined that the quality control process used during production was not adequate to ensure the product met its specified performance requirements. Reference standards used in laboratory and diagnostic testing must consistently meet all specification parameters to ensure the accuracy and reliability of test results.
This product was distributed in Texas. Affected customers include diagnostic laboratories, clinical microbiology facilities, and other testing laboratories that use this reference standard.
Laboratories that have received this product should stop using the recalled lot and contact Microbiologics Inc for replacement or return information. Users should review any quality control testing or validation procedures that used this reference standard.
The recalled product
- Product
- Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
- Manufacturer
- Microbiologics Inc
- Hazard
- specification-non-compliance
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 HE0069N
- Lot HE0069-02-1 UDI: 10845357043990
Distribution
Distributed nationwide across the United States.
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