Z-1400-05

Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100

Name: Z-1400-05 Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
Creator: Abbott Laboratories Diagnostic Div
Published: 2005-08-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-08-05 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories Diagnostic Div began a recall of Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 on 2005-08-05. The reason FDA records is "The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total...". 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-1400-05
Status: Terminated
Initiated: 2005-08-05
Posted: 2005-08-24
Terminated: 2012-03-07
Recalling firm: Abbott Medical
Product: Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.
Root cause tag: manufacturing process
FDA root cause: Other
Action: A Device Correction letter correcting the transposition of the calibrator values dated August 5, 2005, was mailed to all customers receiving the Clinical Chemistry Bilirubin Calibrator, LN 1E66-03, Lot Number 20881M100.
Quantity in commerce: 213
Distribution: Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
Product codes and lots: List # 1E66-03; Lot #20881M100

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