Recall Z-0064-2019 ยท KPA Slide Stainer, Automated
Leica Microsystems, Inc.
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
| Date | Jun 13, 2018 |
| Status | Terminated |
| Reason | These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user. |
| Root cause | Device Design |
| Action | On approximately 06/13/2018 sent a Field Action Notices to consignees. Instructions included to make arrangements with their Leica Service Engineer to correct affected devices, ensure all appropriate personnel are made aware of the recall, and complete and return the Field Action Notice Return Response Form to confirm receipt and understanding of the recall notice. |
| Quantity | 67 units |
| Distribution | Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.