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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Clinical Chemistry Aeroset/Architect Bilirubin Calibrator

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  Class 2 Device Recall Abbott Clinical Chemistry Aeroset/Architect Bilirubin Calibrator see related information
Date Initiated by Firm August 10, 2007
Create Date June 25, 2015
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-0288-2008
Recall Event ID 45333
510(K)Number K981706  
Product Classification Bilirubin Calibrator - Product Code JIX
Product Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064
Code Information List Number (LN) 1E66-03 Lot Number: 38436M100 (Expires September 30, 2007); List Number (LN) 1E66-04 Lot Numbers: 41456M100 (Expires December 31, 2007), 42396M100 (Expires April 30, 2008), 48616M100 (Expires July 31, 2007)
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Mark Littlefield
972-518-6062
Manufacturer Reason
for Recall		 Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.
FDA Determined
Cause 2		 Material/Component Contamination
Action An August 10, 2007, Product Correction letter was provided to all ARCHITECT cSystem and AEROSET System customers. The letter advises that changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the NIST standard 916a. Revised Bilirubin values for the calibrator lot numbers in this recall are attached to the recall notice. Six necessary actions were listed in the recall notice as: 1) Identify the lot numbers of Clinical Chemistry Bilirubin Calibrator(s) currently in use. 2) Discard the value sheet and replace with the appropriate values provided with the recall letter. 3) Enter the revised Bilirubin values. 4) Calibrate the assays. 5) Evaluate your quality control. 6) Evaluate your reference range and any shifts in patient results.
Quantity in Commerce 7,033 units total worldwide
Distribution Worldwide: USA, Canada, Mexico, Guatemala, Puerto Rico, Germany, Hong Kong, Singapore, Australia, New Zealand, Jamaica, Venezuela, Columbia, Ecuador, Chile, Uruguay, Argentina, Brazil, Thailand, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, and El Salvador
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 = JIX and Original Applicant = ABBOTT LABORATORIES
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