Agency classClass IIOur severity:Severe FDA (Devices)·Z-0281-2019·Announced 2018-11-07

Leica BOND Slide Labeler Printers Recalled for Fire Hazard

Leica Microsystems is recalling BOND Slide Labeler Zebra Printers because the power supply unit may overheat or cause a fire due to an improperly-mixed phosphorus compound.

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 fire hazard, which is a significant injury/property-damage risk, meeting the criteria for a Severe (Score 4) classification under the rubric for significant injury/property-damage reports or high-risk defects.

Plain-English summary

Leica Microsystems, Inc. is recalling the BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, which are used with BOND-III and BOND-MAX instruments. The recall involves 876 devices distributed in the United States and Canada. The distribution was nationwide in the U.S., including government and military channels, with foreign distribution limited to Canada.

The recall is being issued because the power supply unit (PSU) for the printer can potentially overheat or cause a fire hazard. This risk exists because the PSU could contain an improperly-mixed phosphorus compound. The affected units are identified by specific PSU part numbers and date codes: Model TLP3842 with PSU Part Number 808113-001 or P1028888-001, and Model GX4301 with PSU Part Number 808101-001. Date codes range from 0639XX through 1253XX.

Users of these devices should check their printer models and PSU part numbers against the affected codes listed in the recall notice. If the device is affected, users should stop using the printer and contact Leica Microsystems for instructions on repair or replacement.

The recalled product

Product: BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Manufacturer: Leica Microsystems, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: fire
overheating
Affected units: 876

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 (2)

where YY=year and WW=week)
where YY=year and WW=week).

Distribution

Distributed nationwide across the United States.

Same manufacturer · Leica Microsystems, Inc.

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Same hazard · fire