Abbott Laboratories Diagnostic Div AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
Brand
Abbott Laboratories Diagnostic Div
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Abbott Laboratories Diagnostic Div is recalling AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30 due to False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026