—#46858

Product

FP1000 Cell Preparation System Part Number 624922

FDA product code: LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Software Version 1.0

Why it was recalled

During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.

Root cause (FDA determination)

Other

Action the firm took

A Product Corrective Action letter was sent on June 26, 2006 informing users that during the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results. To reduce the risk of incorrect results from dripping fluid, users were advised to remove all patient samples, reagents, controls, and calibrators before initiating the shutdown cycle of the Beckman Coulter FP1000. Software will be modified in the next version to prevent the possibility of dripping bleach during the shutdown cycle. The Product Corrective Action letter is to be maintained as part of the customer''s laboratory Quality System documentation. The enclosed Response Form is to be completed and returned within 10 days to the recalling firm. Customers are also advised to contact the firm or their local Beckman Coulter Representative if there are questions.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2006-06-26
Posted by FDA: 2006-08-31
Terminated: 2012-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.