UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
This recall has been terminated (originally issued August 26, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- May 15, 2006
- Posted
- August 26, 2006
- Terminated
- April 8, 2013
- Recall Number
- Z-1440-06
- Quantity
- 524
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.
Distribution
Nationwide and Canada
Lot / Code Info
Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Root Cause
Other
Action Taken
A Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail.