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Terminated

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

FDA Recall Z-1400-05 · Posted 2005-08-24

Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Product CodeJIX
Date Initiated2005-08-05
Date Terminated2012-03-07
Product Quantity213

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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