Recalls / —
—#46712
Product
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 product code
- NDW — Assay, Porphyrin, Spectrophotometry, Lithium
- Device class
- Class 2
- Medical specialty
- Clinical Toxicology
- Affected lot / code info
- Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2006-05-15
- Posted by FDA
- 2006-08-26
- Terminated
- 2013-04-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #46712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.