|Date Initiated by Firm
||April 04, 2013
||June 03, 2013
|Recall Event ID
||Cassettes, tissue - Product Code IDZ
||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.
||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.
| Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
|For Additional Information Contact
||Ms. Katya Magee
|An LPC Fine Mesh Cassette failed to stay closed during processing operations.
||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
||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.