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
FDA Recall Z-1440-06 · Posted 2006-08-26
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeNDW
Date Initiated2006-05-15
Date Terminated2013-04-08
Product Quantity524
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.
Firm Action
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
Distribution Pattern
Nationwide and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.