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U.S. Department of Health and Human Services

Class 2 Device Recall HistoCare SPECTRA ST Stainer

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  Class 2 Device Recall HistoCare SPECTRA ST Stainer see related information
Date Initiated by Firm June 13, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on March 18, 2019
Recall Number Z-0064-2019
Recall Event ID 80916
Product Classification Slide stainer, automated - Product Code KPA
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.
Code Information Serial Numbers: 70-78, 111-112, 120-175
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact
800-225-8867
Manufacturer 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 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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