Leica Cryostats Recalled for Missing Flammable Spray Warning
Leica Microsystems is recalling 17,179 cryostats because the labels lack warnings about the fire risk associated with flammable freezing sprays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the hazard can cause 'serious injuries,' which aligns with the High severity criteria for risk-of-harm products.
Plain-English summary
Leica Microsystems, Inc. is recalling 17,179 Leica Cryostats, which are used to produce frozen sample sections for biological, medical, and industrial applications. The recall involves specific models including the CM1950, CM1860/UV, CM1520, CM3050 S, CM1850UV, CM1850, CM1510 S, and CM1100, with affected units identified by specific serial number ranges.
The recall was initiated because the current labeling does not include a specific warning regarding the usage of flammable freezing sprays. The source text notes that such sprays can potentially ignite and cause serious injuries. The devices were distributed to all 50 US states, the District of Columbia, and Canada.
Users of these devices should check their serial numbers against the affected ranges provided by the manufacturer. If a device is affected, users should contact Leica Microsystems for instructions on how to proceed, as the missing warning poses a potential fire hazard when using flammable sprays.
The recalled product
- Product
- Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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