Z-0288-2008

Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List...

Name: Z-0288-2008 Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List...
Creator: Abbott Laboratories Inc.
Published: 2007-08-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-08-10 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories Inc. began a recall of Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott... on 2007-08-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0288-2008
Status: Terminated
Initiated: 2007-08-10
Posted: 2015-06-25
Terminated: 2012-04-19
Recalling firm: Abbott Medical
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
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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)

Product code JIX

K981706Class IIAmm Cal, Bil Cal, CO2 Cal, Hdl Cal, Iron/mg Cal, Ldl Cal, Mc Cal, Upro Cal, and Ise Calibrator Levels 1 and 2Abbott Laboratories / cleared 1998-07-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)