FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
- Recall number
- Z-1133-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
- Status
- Terminated
- Initiated
- 2001-12-10
- Posted
- 2003-08-13
- Terminated
- 2003-08-12
- Reason
- Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.
- Root cause
- Other
- Action
- Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.
- Quantity
- 787
- Distribution
- Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand.
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["K983212"]
- 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