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Terminated

ACL Futura Instrument Analyzer

FDA Recall Z-0736-04 · Posted 2004-07-20

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeJPA
Date Initiated2004-03-04
Date Terminated2016-01-28
Product Quantity1450 units

Reason for Recall

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

Firm 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.

Root Cause

Other

Distribution Pattern

Florida Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951891ACL FUTURA COAGULATION SYSTEMInstrumentation Laboratory CO · 1995-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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