Recall Z-1729-2019— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2019-05-03, terminated 2023-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.. 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..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-03
- Terminated
- 2023-09-28
- Firm location
- Buffalo Grove, IL, United States
Product description
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.