FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: Clinical Chemistry Uric Acid; LN 7D76-20
- Recall number
- Z-0769-04
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- Clinical Chemistry Uric Acid; LN 7D76-20
- Status
- Terminated
- Initiated
- 2004-03-18
- Posted
- 2004-07-20
- Terminated
- 2012-02-10
- Reason
- Unacceptable upward drift of results in control runs within 24 hour period.
- Root cause
- Other
- Action
- Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.
- Quantity
- 796 kits.
- Distribution
- Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad.
- Lot, serial or model codes
- Lot number: 95015HW00
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CDO
- 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