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.
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: 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
- Hazard
- inadequate-release-testing
- quality-control-defect
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
Distributed in 18 states:
- AZ
- CT
- DC
- FL
- IL
- IN
- KS
- KY
- MA
- MD
- NC
- NH
- NJ
- NY
- PA
- TX
- UT
- WA
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