Beckman Coulter Inc.: Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.

Recall number

Z-1935-2011

Recalling firm

Beckman Coulter Inc.

Product

Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.

Status

Terminated

Initiated

2010-10-05

Posted

2011-04-12

Terminated

2012-07-25

Reason

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.

Root cause

Pending

Action

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

Quantity

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, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.

Lot, serial or model codes

All Serial Numbers.

510(k) numbers

["K922826"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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