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U.S. Department of Health and Human Services

Class 2 Device Recall ABBOTT Clinical Chemistry Calibrator

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  Class 2 Device Recall ABBOTT Clinical Chemistry Calibrator see related information
Date Initiated by Firm September 12, 2008
Date Posted January 12, 2009
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-0580-2009
Recall Event ID 49597
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04.

The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.
Code Information Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100.
Recalling Firm/
Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact
Manufacturer Reason
for Recall
The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and List Number 6L45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias. Because of these findings, a new Total Bilirubin calibrator value assignm
FDA Determined
Cause 2
Component design/selection
Action On September 12, 2008, a Product Correction letter with an attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. The letter instructed customers to take the following actions: 1. Identify the lot number(s) of Clinical Chemistry Bilirubin Calibrator currently used in your laboratory; 2. Replace the calibrator value sheet with the appropriate attachment provided with this letter. Discard the previous calibrator value sheet; 3. Configure the revised Total Bilirubin calibrator values provided in the Attachments, for the appropriate calibrator lot number and reagent list number. ARCHITECT cSystems: Refer to System Configuration in Section 2, Installation Procedures and Special Requirements in the Architect System Operations Manual. AEROSET: Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual; 4. Calibrate the Total Bilirubin assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory; 5. Evaluate your quality control. Shifts in quality control and proficiency testing samples may vary among laboratories and should be evaluated according to your laboratory procedures. NOTE: Refer to the Attachments (E and F) for the representative shift with the revised calibrator values (Patient sample and Control/QC recovery); and 6. Evaluate your reference range and any shifts in patient results. It is recommended that each laboratory established its own expected ranges, which may be unique to the population it serves. Please retain this communication for future reference. If you have forwarded any Clinical Chemistry Bilirubin Calibrator to another laboratory, please provide a copy of this letter to them. For questions, please contact ABBOTT Customer Service at 877-422-2688 (or 877-4ABBOTT). Customers outside of the
Quantity in Commerce 7,101 units worldwide (2,267 units in US).
Distribution Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.
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.