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U.S. Department of Health and Human Services

Class 2 Device Recall QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL

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  Class 2 Device Recall QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL see related information
Date Initiated by Firm June 01, 2007
Date Posted January 17, 2009
Recall Status1 Terminated 3 on February 18, 2009
Recall Number Z-0513-2009
Recall Event ID 48190
510(K)Number K925256  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Quantimetrix QuanTscopics Urine Microscopics Control.

QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
Code Information Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.
Recalling Firm/
Manufacturer		 Quantimetrix Corporation
2005 Manhattan Beach Blvd
Redondo Beach CA 90278-1205
For Additional Information Contact
310-536-0006
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		 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 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.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = QUANTIMETRIX CORP.
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