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U.S. Department of Health and Human Services

Class 2 Device Recall Leica HistoCore SPECTRA CV Coverslipper

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  Class 2 Device Recall Leica HistoCore SPECTRA CV Coverslipper see related information
Date Initiated by Firm September 04, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on July 10, 2020
Recall Number Z-0019-2019
Recall Event ID 80986
Product Classification Device for sealing microsections - Product Code KIM
Product Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Code Information Serial Number 102
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Adam Blunier
847-821-3462
Manufacturer Reason
for Recall		 Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
FDA Determined
Cause 2		 Process design
Action The firm issued a Field Action Notice by letter on 09/05/2018. The notice explained the issue and the possible hazard. The firm will schedule a visit with a service engineer to perform the correction.
Quantity in Commerce 1 unit
Distribution Distribution in US state of MO.
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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