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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems Total T4 Calibrators

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  Class 2 Device Recall Access Immunoassay Systems Total T4 Calibrators see related information
Date Initiated by Firm August 26, 2010
Date Posted August 16, 2011
Recall Status1 Terminated 3 on July 11, 2012
Recall Number Z-3027-2011
Recall Event ID 59239
510(K)Number K023369  
Product Classification Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
Product Access¿ Immunoassay Systems Total T4 Calibrators,

Part Number: 33805,

Subsequent Product Code: JIS

The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.
Code Information Lot Number: 917074, 008534  Expiration Date: 917074 (12/31/10), 008534 (2/28/11) 
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 Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.
Quantity in Commerce 2495 units total (2492 in US)
Distribution Worldwide Distribution-USA (nationwide) and the country of Canada.
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 = KLI and Original Applicant = BECKMAN COULTER, INC.
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