Abbott Laboratories Inc. Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
Brand
Abbott Laboratories Inc.
Lot Codes / Batch Numbers
List Numbers: 7D80-20 and 7D80-30, Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00
Products Sold
List Numbers: 7D80-20 and 7D80-30; Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00
Abbott Laboratories Inc. is recalling Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30 due to Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.
Recommended Action
Per FDA guidance
The firm initiated the recall on 06/01/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions for modification to the SmartWash feature in the Lipase Assay Configuration in order to prevent Acetaminophen from contaminating Lipase.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026