FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc.: Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
- Recall number
- Z-1232-2007
- Recalling firm
- Abbott Laboratories Inc.
- Product
- Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
- Status
- Terminated
- Initiated
- 2007-06-01
- Posted
- 2007-09-18
- Terminated
- 2012-04-05
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 7260
- Distribution
- Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.
- Lot, serial or model codes
- List Numbers: 7D80-20 and 7D80-30; Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28