Mycoplasma genitalium Control Panel Distributed Without Proper Release Testing
Microbiologics Inc is recalling Mycoplasma genitalium Control Panel units that did not undergo proper release testing before distribution. Affected lots were distributed across the U.S. and internationally.
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: This is an FDA Class II recall involving a quality control procedural defect (inadequate release testing). No illnesses or injuries have been reported, and the hazard is manufacturing/quality-related rather than direct patient harm, consistent with a precautionary recall.
Plain-English summary
Microbiologics Inc is recalling Mycoplasma genitalium Control Panel (Inactivated Pellet) units in lot numbers 8240-08 through 8240-16 (Catalog 8240). The product did not undergo proper release testing before distribution.
Affected units were distributed to customers in multiple U.S. states: Arizona, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah, and Washington. International distribution occurred to Belgium, Finland, France, Germany, Ireland, Sweden, the United Kingdom, and Vietnam.
Microbiologics Inc is notifying customers who received the affected lots and asking them to return the product. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Mycoplasma genitalium Control Panel (Inactivated Pellet)
- Manufacturer
- Microbiologics Inc
- Affected units
- 80
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 (10)
- Catalog 8240
- Lots: 8240-08
- 8240-09
- 8240-10
- 8240-11
- 8240-12
- 8240-13
- 8240-14
- 8240-15
- 8240-16 (UDI: 70845357043053)
Distribution
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