Recall Z-0064-2019
Leica Microsystems, Inc. · initiated June 13, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial Numbers: 70-78, 111-112, 120-175
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0064-2019
- Initiated
- June 13, 2018
- Terminated
- March 18, 2019
- Product code
- KPA – Slide Stainer, Automated
- 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
- Recalling firm
- Leica Microsystems, Inc., Buffalo Grove, IL