Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
Brand
Abbott Laboratories Diagnostic Div
Lot Codes / Batch Numbers
List # 1E66-03, Lot #20881M100
Products Sold
List # 1E66-03; Lot #20881M100
Abbott Laboratories Diagnostic Div is recalling Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 due to The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator v. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026