Leica Microsystems, Inc. recalls Leica Cryostats, used to produce frozen sample sections for
Recalled Product
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Hazard / Issue
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
Issued by
FDA
Distribution: Distributed to Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming. Distributed internationally to Canada.
Lot/Code Info: Leica CM1950 - All devices with serial number: 8092; 8091; 8089 to 8087; 8081; 8078; 8077; 8073; 8071 to 8067; 8064 to 8062; 8058 to 8053; 8051 to 8049; 8047; 8043; 8040; 8038 to 8033; 8031 to 8025; 8023 to 8004; 8002 to 7940; 7938 to 7892; 7890 to 7469; 7466; and all devices with serial number lower than 7466. Leica CM1860/UV - All devices with serial number: 4201; 4200;4196; 4193; 4192; 4188; 4186 to 4184; 4180; 4179; 4173 to 4170; 4168; 4166 to 4160; 4158; 4157; 4154 to 4152; 4149; 4147; 4145 to 4135; 4133 to 4092; 4090; and all devices with serial number lower than 4090. Leica CM1520 - All devices with serial number: 1450; 1448; 1446 to 1444; 1442; 1439; 1437; and all devices with serial number lower than 1437. Leica CM3050 S - All devices with serial number: 7398; 7396 to 7394; 7392; 7398 to 7387; 7385 to 7381; 7379; and all devices with serial number lower than 7379. Leica CM1850UV - 2822; and all devices with serial number lower than 2822. Leica CM1850 - 7265; and all devices with serial number lower than 7265. Leica CM1510 S - 6600; and all devices with serial number lower than 6600. Leica CM1100 - 1418; and all devices with serial number lower than 1418