Mycoplasma genitalium Control Panel (Inactivated Pellet)
Check against the official notice below — it lists the full affected range.
Microbiologics Inc is recalling its Mycoplasma genitalium Control Panel (Inactivated Pellet) because the distributed product did not undergo proper release testing. The recall involves 80 units distributed across multiple U.S. states including Arizona, Connecticut, the District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah, and Washington. The product was also distributed outside the United States to Belgium, Finland, France, Germany, Ireland, Sweden, the United Kingdom, and Vietnam.
The affected product includes Catalog 8240 in Lots 8240-08 through 8240-16 (UDI: 70845357043053). The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Distributed product did not undergo proper release testing.
Reason for recall: Distributed product did not undergo proper release testing. Distribution: Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam Quantity: 80 units Lot/code info: Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.