Recall Z-1729-2019 ยท IDP Microtome, Cryostat
Leica Microsystems, Inc.
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
| Date | Jun 4, 2019 (initiated May 3, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Leica Biosystems notified consignees of the recall on about 05/03/2019 via "Urgent: Medical Device Recall for Cryostat Devices" letter. Instructions included to immediately attach the provided adhesive label onto the devices and add a supplemental sheet to the current instructions for use (IFU). Consignees were also instructed to provide the recall notification to all employees who need to be aware within the organization or any organization where the affected devices have been transferred, and to complete and return the response form. The form can be faxed to +1 847-236-3747 or emailed to |
| Quantity | 17,179 devices total (4,835 US, 12,344 OUS) |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.