Z-0281-2019Class II

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

Name: Z-0281-2019 BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX...
Creator: Leica Microsystems, Inc.
Published: 2018-09-17
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2018-09-17 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments on 2018-09-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0281-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-17
Posted: 2018-10-26
Terminated: 2020-08-21
Recalling firm: Leica Microsystems, Inc.
Product: BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Product code: KPA Slide Stainer, Automated
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 876 devices (in U.S. and Canada)
Distribution: Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.
Product codes and lots: Zebra Printer Model TLP3842 - Affected PSU Part Number 808113-001 or P1028888-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week); Zebra Printer Model GX4301 - Affected PSU Part Number 808101-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0281-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-26

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)