FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: ACL Futura Instrument Analyzer
- Recall number
- Z-0736-04
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- ACL Futura Instrument Analyzer
- Status
- Terminated
- Initiated
- 2004-03-04
- Posted
- 2004-07-20
- Terminated
- 2016-01-28
- Reason
- Software may cause instrument to omit step causing reagent carrover which may effect patient test result
- Root cause
- Other
- Action
- Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.
- Quantity
- 1450 units
- Distribution
- Florida Canada
- Lot, serial or model codes
- Software prior to Version V3.5
- 510(k) numbers
- ["K951891"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 1217183
- Firm city
- Lexington
- Firm state
- MA
- 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