Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
FDA device recall Z-1400-05 · posted 2005-08-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 213
- Distribution
- Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
- Date initiated
- 2005-08-05
- Date posted
- 2005-08-24
- Date terminated
- 2012-03-07
- Location
- South Pasadena, CA
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