AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
FDA Recall Z-0240-04 · Posted 2003-12-18
Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Product CodeCDQ
Date Initiated2003-11-24
Date Terminated2012-01-25
Product QuantityAll lots.
Reason for Recall
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
Firm Action
Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.
Root Cause
Other
Distribution Pattern
Nationwide and Mexico, Brazil, Germany, Singapore, Grand Cayman, Venezuela, Puerto Rico, Hong Kong, Australia, Columbia, Dominican Republic, China, Trinidad, Argentina, Canada, New Zealand, Bahamas
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.