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Class 3 Device Recall Abbott Clinical Chemistry Bil Cal |
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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
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Product |
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 |
Code Information |
List # 1E66-03; Lot #20881M100 |
Recalling Firm/ Manufacturer |
Abbott Laboratories Diagnostic Div 820 Mission St South Pasadena CA 91030-3142
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For Additional Information Contact |
Linda Morris 972-518-6711
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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