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U.S. Department of Health and Human Services

Class 2 Device Recall LPC Fine Mesh Cassettes

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  Class 2 Device Recall LPC Fine Mesh Cassettes see related information
Date Initiated by Firm April 04, 2013
Date Posted June 03, 2013
Recall Status1 Open3, Classified
Recall Number Z-1446-2013
Recall Event ID 64968
Product Classification Cassettes, tissue - Product Code IDZ
Product LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
Code Information 1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310;

2) Part No.: 14060546846; Batch No.s: 1034710114;

3) Part No.: 14060546845; Batch No.s: 1021420914;

4) Part No.: 14060546933; Batch No.s: 82801-0217;

5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204;

6) Part No.: 14060546852; Batch No.s: 1101910322;

7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803;

8) Part No.: 14060546847; Batch No.s: 913920827.
Recalling Firm/
Manufacturer
Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Ms. Katya Magee
847-405-5413
Manufacturer Reason
for Recall
An LPC Fine Mesh Cassette failed to stay closed during processing operations.
FDA Determined
Cause 2
Device Design
Action A Medical Device Correction letter dated April 17, 2013 was sent to customers via USPS 1st class mail. The product issue was described and recommended actions were provided. Customers were requested to acknowledge receipt of the letter by fax-back. Customer questions were directed to (847) 405-5413.
Quantity in Commerce 20,160 units
Distribution Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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