FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
- Recall number
- Z-0915-05
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
- Status
- Terminated
- Initiated
- 2005-05-19
- Posted
- 2005-06-21
- Terminated
- 2006-12-06
- Reason
- Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
- Root cause
- Other
- Action
- Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005.
- Quantity
- 617 units
- Distribution
- Nationwide Canada
- Lot, serial or model codes
- Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354
- 510(k) numbers
- ["K002400","K033414","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