FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: Clinical Chemistry Urea Nitrogen
- Recall number
- Z-0550-04
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- Clinical Chemistry Urea Nitrogen
- Status
- Terminated
- Initiated
- 2003-11-24
- Posted
- 2004-02-26
- Terminated
- 2012-02-07
- Reason
- Low results due to contaminant.
- Root cause
- Other
- Action
- Each domestic customer will receive the recall letter by direct mailing. Foreign affiliates will be responsible for distributing letters to thier customers. Letters were sent 11/24/2003. A reply form was enclosed.
- Quantity
- 568
- Distribution
- Nationwide, Mexico, Argentina, Germany, Australia, Venezuela, Puerto Rico, Singapore, New Zealand, Columbia, Canada, Hong Kong, Grand Cayman
- Lot, serial or model codes
- Lots: 05073HW00 04022Hw00 03041HW00
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- 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