Leica Microsystems, Inc. Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 LMGRA@ leica-microsystems.com Questions or concerns can be directed to Adam Blunier at Adam.Blunier@leicabiosystems.com. On 09/16/2019, Leica Biosystems provided an updated "Urgent: Medical Device Recall for Cryostat Devices" letter to all affected customers. The letter contained the same instructions, but instructed customers that enlarged, updated adhesive labels were provided and should be applied to affected equipment on top of the previously provided smaller label.

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC