UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Soft
FDA device recall Z-1440-06 · posted 2006-08-26 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDW
- Quantity affected
- 524
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-05-15
- Date posted
- 2006-08-26
- Date terminated
- 2013-04-08
- Location
- Brea, CA
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