FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
- Recall number
- Z-0172-04
- Recalling firm
- Abbott Laboratories, Inc
- Product
- ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
- Status
- Terminated
- Initiated
- 2002-05-08
- Posted
- 2004-07-20
- Terminated
- 2003-11-26
- Reason
- If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
- Root cause
- Other
- Action
- Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.
- Quantity
- 1,167 units worldwide
- Distribution
- States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri, Louisiana, Oregon, Wisconsin, Hawaii, Connecticut, New Hampshire, Massachusetts, Washington, South Carolina, Mississippi, Alabama, and Tennessee, and the following foreign countries: Austria, Denmark, Germany, Italy, Poland, South Africa, Sweden, England, Colombia, Australia, Japan, New Zealand, Belgium, Finland, Greece, Netherlands, Portugal, Romania, Turkey, Canada, Mexico, Hong Kong, Korea, Taiwan, Czech Republic, France, Israel, Norway, Saudi Arabia, Spain, United Arab Emirates, Brazil, Venezuela, India, Malaysia, and Thailand.
- Lot, serial or model codes
- All Serial numbers
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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