BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1640-2015 · Initiated April 29, 2015

    Recall

    Recall Number
    Z-1640-2015
    Event Number
    71178
    Firm
    Richard-Allan Scientific Company
    FEI Number
    1831638
    Product Code
    LEA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 29, 2015
    Posted
    May 21, 2015
    Terminated
    March 9, 2016
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590

    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.

    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

    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.

    Quantity

    506 cases = 20 of Product Code 44041; 37 of Product Code 44042; 185 of Product Code 9990370; 92 of Product Code 9990371; 27 of Product Code 9990375