||June 03, 2013
|Recall Event ID
Cassettes, tissue -
||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
|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 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.