Events

Recall of Lerner Laboratories Mucolexx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard-Allan Scientific Company.

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
    71178
  • Event Risk Class
    Class 2
  • Event Number
    Z-1640-2015
  • Event Initiated Date
    2015-04-29
  • Event Date Posted
    2015-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136397
  • 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
    Richard allan scientific (ras) is initiating a recall of mucolytic agent and mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of mucolexx.
  • Action
    Richard Allan Scientific (RAS) initiated a voluntary recall of Mucolexx and Mucolytic Agent due to fungal contamination on 5/1/2015 via certified mail to all customers who received the affected. Customers were asked to return a repsonse form, and dispose or return all recalled products. Please contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher

Device

Lerner Laboratories Mucolexx
  • Model / Serial
    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L-Product Codes 44041& 44042. Lot Numbers & EXP Dates: 301362-Jun-2016; 272123-Sep-2015; 317218-Dec-2016; 266312-Jul-2015.  Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL , Product Code 9990370, 9990371 & 9990375; Lot Numbers & EXP Dates: 328311-Mar-2017; 324252-Feb-2017; 314543-Dec-2016; 304548-Jul-2016; 289566-Mar-2016; 282598-Dec-2015; 276182-Nov-2015; 267432-Aug-2015; 255776-Apr-2015; 311289-Oct-2016; 299148-Jun-2016; 285035-Feb-2016; 273852-Oct-2015; 263847-Jul-2015; 312363-Oct-2016 & 255325-Apr-2015
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A; IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: Bangladesh, Canada, China, Costa Rica, Dubai, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
  • Product Description
    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; || Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL || Product Usage: || A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • Manufacturer Address
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA