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U.S. Department of Health and Human Services

Class 3 Device Recall Access Total T3 Reagent

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 Class 3 Recall
Access Total T3 Reagent
see related information
Date Posted August 20, 2012
Recall Status1 Terminated on March 14, 2013
Recall Number Z-2227-2012
Recall Event ID 62791
Premarket Notification
510(K) Numbers
K940833  K955435  K973966 
Product Classification Radioimmunoassay, Total Triiodothyronine - Product Code CDP
Product Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
Code Information All Lots
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.
FDA Determined
Cause 2
DESIGN: Device Design
Action Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The PCA letter informed the customers of the problem identified and the actions to be taken. Customers were informed to stop SDA usage as an alternative dilutent and that the S0 dilutent is to be used for manual dilution of the patient sample for Total T3. They will also be informed to no longer use the On Board Dilution (OBD) option for Total T3. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding this notification were instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-4941.
Quantity in Commerce 117,385 units total (33,918 units in US)
Distribution Worldwide Distribution - USA (nationwide), Canada, and internationally.
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 = CDP and Original Applicant = BECKMAN INSTRUMENTS, INC.
510(K)s with Product Code = CDP and Original Applicant = BIO-RAD LABORATORIES, INC.
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