UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. An in vitro diagnostic device used for the quantitative,

FDA device recall Z-1936-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack.

Action taken

The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration. New bottles are opaque white in color. Signs of deterioration include: o Any color change to the bottle (yellow, orange or pink) o Cracking o Crazing (spider web cracking) Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future. Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification. Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i

Root cause

Pending

Status

Terminated

Product code

JJE

Quantity affected

7700 units total (3178 in US)

Distribution

Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Cana

Date initiated

2010-10-05

Date posted

2011-04-12

Date terminated

2012-07-25

Location

Brea, CA

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