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U.S. Department of Health and Human Services

Class 2 Device Recall Access Ostase QC

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  Class 2 Device Recall Access Ostase QC see related information
Date Initiated by Firm November 10, 2011
Date Posted March 21, 2012
Recall Status1 Terminated 3 on June 26, 2012
Recall Number Z-1239-2012
Recall Event ID 61214
510(K)Number K994277  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product Access Ostase QC, Part Number: 37309.

The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Code Information Lot Numbers: Expiration dates: 009091 10/10/2010  109636 09/30/2011 013491 10/31/2010  113465 10/31/2011 013492 11/30/2010  113969 10/31/2011 014488 12/31/2010  114261 11/30/2011 015211 02/28/2011  115485 12/31/2011 018855 03/31/2011  116660 01/31/2012 020420 04/30/2011  118211 02/28/2012 021285 05/31/2011
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.
FDA Determined
Cause 2
Process design
Action Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.
Quantity in Commerce 4961 units total (1321 units in US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
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 = JJX and Original Applicant = BECKMAN COULTER, INC.
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