Recall Z-0281-2019 ยท KPA Slide Stainer, Automated
Leica Microsystems, Inc.
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
| Date | Sep 17, 2018 |
| Status | Terminated |
| Reason | 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 | 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 | 876 devices (in U.S. and Canada) |
| Distribution | Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.