Z-0736-04

ACL Futura Instrument Analyzer

Name: Z-0736-04 ACL Futura Instrument Analyzer
Creator: Instrumentation Laboratory Co.
Published: 2004-03-04
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2004-03-04 / Terminated / root cause: software

FDA source

Instrumentation Laboratory Co. began a recall of ACL Futura Instrument Analyzer on 2004-03-04. The reason FDA records is "Software may cause instrument to omit step causing reagent carrover which may effect patient test result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0736-04
Status: Terminated
Initiated: 2004-03-04
Posted: 2004-07-20
Terminated: 2016-01-28
Recalling firm: Instrumentation Laboratory Co.
Product: ACL Futura Instrument Analyzer
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Software may cause instrument to omit step causing reagent carrover which may effect patient test result
Root cause tag: software
FDA 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 in commerce: 1450 units
Distribution: Florida Canada
Product codes and lots: Software prior to Version V3.5

Product code JPA

K951891Class IIAcl Futura Coagulation SystemInstrumentation Laboratory CO / cleared 1995-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)