Instrumentation Laboratory Co. ACL Advance Instrument Analyzer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACL Advance Instrument Analyzer
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Software version prior to V2.1
Products Sold
Software version prior to V2.1
Instrumentation Laboratory Co. is recalling ACL Advance Instrument Analyzer due to Software may cause instrument to omit step causing reagent carrover which may effect patient test result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software may cause instrument to omit step causing reagent carrover which may effect patient test result
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL
Page updated: Jan 10, 2026