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U.S. Department of Health and Human Services

Class 2 Device Recall SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

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 Class 2 Recall
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
see related information
Date Posted January 17, 2009
Recall Status1 Terminated on February 18, 2009
Recall Number Z-0516-2009
Recall Event ID 48190
Premarket Notification
510(K) Numbers
K010598  K874890  K925256  K970862 
Product Classification Mixture, Hematology Quality Control - Product Code JPK
Product Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.
Code Information Lot Numbers: 38050 and 38060.
Recalling Firm/
Manufacturer
Quantimetrix Corporation
2005 Manhattan Beach Blvd
Redondo Beach, California 90278-1205
Manufacturer Reason
for Recall
This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail. Customers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.
Quantity in Commerce 24,937 sets for all products.
Distribution Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JPK and Original Applicant = QUANTIMETRIX CORP.
510(K)s with Product Code = JPK and Original Applicant = QUANTIMETRIX MEDICAL INDUSTRIES
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