Date Initiated by Firm | April 04, 2013 |
Date Posted | June 03, 2013 |
Recall Status1 |
Terminated 3 on July 21, 2017 |
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 |
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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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