Agency classClass IIOur severity:Severe FDA (Devices)·Z-1717-2020·Announced 2020-04-22

Sysmex CV-11 Sample Unit Recalled for Combustion Hazard

Sysmex America is recalling 40 CV-11 Sample Units because urine spills on the transport track can reach electrical components, creating a potential for smoke, sparks, and combustion.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential for smoke, sparks, and combustion, which constitutes a significant injury or property-damage risk under the severity rubric.

Plain-English summary

Sysmex America, Inc. is recalling 40 units of the Sysmex CV-11 Sample Unit. This device is an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. The recall affects units distributed in Florida, Vermont, and Illinois.

The recall is being issued because excessive amounts of urine that spill on the rack transport track can reach the electrical components of the CV-11 conveyor. This condition presents a potential for smoke and/or sparks, which may create a combustion hazard.

Healthcare facilities and users of the affected devices should stop using the CV-11 Sample Units immediately and contact Sysmex America, Inc. for instructions on how to proceed with the recall.

The recalled product

Product: Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Manufacturer: Sysmex America, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: fire
combustion
Affected units: 40

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)

Serial Numbers: 11201
11202
12310
12311
12312
12313
12941
12942
12997
13875
14170
14171
14172
14173
14174
14175
14278
14279
14280
14962

Distribution

Distributed in 3 states:

Same manufacturer · Sysmex America, Inc.

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Same hazard · fire