Z-0580-2009

ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical...

Name: Z-0580-2009 ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical...
Creator: Abbott Laboratories Inc.
Published: 2008-09-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-09-12 / Terminated / root cause: design

FDA source

Abbott Laboratories Inc. began a recall of 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... on 2008-09-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0580-2009
Status: Terminated
Initiated: 2008-09-12
Posted: 2009-01-12
Terminated: 2012-04-24
Recalling firm: Abbott Medical
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
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
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100.

Product code JIX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)