High FDA (Devices)·Z-1729-2019·Announced 2019-06-12

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.

What this means for you

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.
Category: Medical Device — Laboratory Equipment
Hazard: fire
burn-injury

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

Distributed in 51 states:

Same manufacturer · Leica Microsystems, Inc.

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