FDA-Device2013-11-13Class II
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Beckman Coulter Inc.
Hazard
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.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.
Affected count
4584 units total (1173 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2014Don't want to check this manually?
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