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Terminated

BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments

FDA Recall Z-0281-2019 · Posted None

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeKPA
Date Initiated2018-09-17
Date Terminated2020-08-21
Product Quantity876 devices (in U.S. and Canada)

Reason for Recall

The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.

Firm Action

The recalling firm issued letters dated 9/3/2018 via email on 9/17/2018. A second letter dated 9/24/2018 was issued to update the acknowledgment form to include the number of affected power supply units the consignee destroyed.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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