FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
- Recall number
- Z-0008-06
- Recalling firm
- Abbott Laboratories, Inc
- Product
- ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
- Status
- Terminated
- Initiated
- 2005-02-28
- Posted
- 2005-10-06
- Terminated
- 2005-11-03
- Reason
- Device has incorrect notation associated with therapeutic drug monitoring assays.
- Root cause
- Other
- Action
- Firm sent device correction letters to consignees on 2/28/2005.
- Quantity
- 1,107 units worldwide
- Distribution
- California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand
- Lot, serial or model codes
- List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.
- 510(k) numbers
- ["K980367"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- 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