Recall Z-1400-05 ยท JIX Calibrator, Multi-Analyte Mixture
Abbott Laboratories Diagnostic Div
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
| Date | Aug 24, 2005 (initiated Aug 5, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 213 |
| Distribution | Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.