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