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U.S. Department of Health and Human Services

Class 2 Device Recall Lerner Laboratories Mucolexx

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 Class 2 Device Recall Lerner Laboratories Mucolexxsee related information
Date Initiated by FirmApril 29, 2015
Date PostedMay 21, 2015
Recall Status1 Terminated 3 on March 09, 2016
Recall NumberZ-1640-2015
Recall Event ID 71178
Product Classification Preservative, cytological - Product Code LEA
ProductLerner 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Richard-Allan Scientific Company
4481 Campus Dr
Kalamazoo MI 49008-2590
For Additional Information ContactSarah Rickert
616-544-5628
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Material/Component Contamination
ActionRichard 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
Quantity in Commerce506 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
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
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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