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Class 2 Device Recall SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL |
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Date Initiated by Firm |
June 01, 2007 |
Date Posted |
January 17, 2009 |
Recall Status1 |
Terminated 3 on February 18, 2009 |
Recall Number |
Z-0516-2009 |
Recall Event ID |
48190 |
510(K)Number |
K010598
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Product Classification |
Mixture, hematology quality control - Product Code JPK
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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 CA 90278-1205
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For Additional Information Contact |
310-536-0006
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Manufacturer Reason for Recall |
This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
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FDA Determined Cause 2 |
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
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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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510(K) Database |
510(K)s with Product Code = JPK and Original Applicant = QUANTIMETRIX CORP.
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