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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 Recall
LPC Fine Mesh Cassettes
see related information
Date Posted June 03, 2013
Recall Status1 Open
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, Illinois 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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