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U.S. Department of Health and Human Services

Class 2 Device Recall Leica Cryostats

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  Class 2 Device Recall Leica Cryostats see related information
Date Initiated by Firm May 03, 2019
Date Posted June 04, 2019
Recall Status1 Terminated 3 on September 28, 2023
Recall Number Z-1729-2019
Recall Event ID 82425
Product Classification Microtome, cryostat - Product Code IDP
Product Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Code Information 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
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Adam Blunier
800-225-8867
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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