ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzer

FDA device recall Z-0152-2014 · posted 2013-11-05 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.

Action taken

A customer notification letter dated 9/9/13 was sent to customers who received the ISE REF Valve, Part Number MU3226 for the AU400, AU640, AU2700, AU5400 and the ISE REF Valve, Part Number MU7638 for the AU480, AU680, AU5800 Chemistry Analyzers. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center via http://www.beckmancoulter.com/customersupport/support, via phone at (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJE

Quantity affected

4584 units total (1173 units in US)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.

Date initiated

2013-09-09

Date posted

2013-11-05

Date terminated

2014-09-30

Location

Brea, CA

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