Events

Recall of Device Recall Cyto Jar Fixative

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leica Biosystems Richmond 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
    61276
  • Event Risk Class
    Class 3
  • Event Number
    Z-1331-2012
  • Event Initiated Date
    2012-02-20
  • Event Date Posted
    2012-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107702
  • 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
    Preservative, cytological - Product Code LEA
  • Reason
    Product was distributed with the incorrect lot number and expiration date. the lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product.
  • Action
    The firm, Leica Microsystems, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 17, 2012, via FedEx on February 20, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken. A second letter was sent to the customers on February 29, 2012, clarifying that the incorrect lot number and expiration date was 073014, and should have been 073013. The customers were instructed to discontinue use of the product; return the product and complete and return the enclosed Acknowledgement Form via fax to 815-678-2216 within one week of receiving the notification. If you have any questions, contact the Regulatory Affairs Manager at toll free (800) 225-8867 or email: richmond@leica-microsystems.com.

Device

Device Recall Cyto Jar Fixative
  • Model / Serial
    item #3801825, reorder #01825, lot #073013
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: Michigan, Missouri and New York.
  • Product Description
    Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA || The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.
  • Manufacturer
    Leica Biosystems Richmond Inc.

Manufacturer

Leica Biosystems Richmond Inc.
  • Manufacturer Address
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA