Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
This recall has been terminated (originally issued August 24, 2005).
- Recall Initiated
- August 5, 2005
- Posted
- August 24, 2005
- Terminated
- March 7, 2012
- Recall Number
- Z-1400-05
- Quantity
- 213
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
Lot / Code Info
List # 1E66-03; Lot #20881M100
Root Cause
Other
Action Taken
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.