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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott Clinical Chemistry Bil Cal

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  Class 3 Device Recall Abbott Clinical Chemistry Bil Cal see related information
Date Initiated by Firm August 05, 2005
Date Posted August 24, 2005
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-1400-05
Recall Event ID 32959
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
Code Information List # 1E66-03; Lot #20881M100
Recalling Firm/
Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Linda Morris
Manufacturer Reason
for Recall
The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.
FDA Determined
Cause 2
Action A Device Correction letter correcting the transposition of the calibrator values dated August 5, 2005, was mailed to all customers receiving the Clinical Chemistry Bilirubin Calibrator, LN 1E66-03, Lot Number 20881M100.
Quantity in Commerce 213
Distribution Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
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.