Recall of LPC Fine Mesh Cassettes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leica Microsystems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64968
  • Event Risk Class
    Class 2
  • Event Number
    Z-1446-2013
  • Event Initiated Date
    2013-04-04
  • Event Date Posted
    2013-06-03
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cassettes, tissue - Product Code IDZ
  • Reason
    An lpc fine mesh cassette failed to stay closed during processing operations.
  • 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.

Device

  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Manufacturer Parent Company (2017)
  • Source
    USFDA