ACL Advance Instrument Analyzer
This recall has been terminated (originally issued July 20, 2004).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- March 4, 2004
- Posted
- July 20, 2004
- Terminated
- January 28, 2016
- Recall Number
- Z-0737-04
- Quantity
- 760 units
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Software may cause instrument to omit step causing reagent carrover which may effect patient test result
Distribution
Florida Canada
Lot / Code Info
Software version prior to V2.1
Root Cause
Other
Action Taken
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.
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