FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
- Recall number
- Z-0010-06
- Recalling firm
- Abbott Laboratories, Inc
- Product
- ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
- Status
- Terminated
- Initiated
- 2005-09-14
- Posted
- 2005-10-06
- Terminated
- 2007-09-25
- Reason
- Software deficiency causing potential shift in absorbance readings for test results.
- Root cause
- Other
- Action
- Firm sent device correction letter to consignees on 9/14/2005.
- Quantity
- 1,107 units
- Distribution
- Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman
- Lot, serial or model codes
- All serial numbers, List number 1G06-01
- 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