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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Recall Number Z-0152-2014
Classification Class II
Code Info AU400, Item Code: 5427200 5427400 5427600 N1254000 N1254200 N1254400 N1254600 N1255000 n1255200 N1257400 N2571700 N2571800 N3658500 N3658700 N3658800 N3659000 N3659400 N3912300 N9020723 N9020724 AU400 OPA, Item Code: 5427300 5427900 N1257700 AU640, Item Code: 5900100 5900400 5900600 N1255700 N1255900 N1256100 N1256300 N1256700 N2572800 N3660900 N3661200 N3661300 N3661500 N3661700 N3661900 AU640 OPA, Item Code: 590220 5902400 A92928 A92929 AU2700, Item Code: 5996300 5996500 5998100 N1465100 N1465300 N1465500 N1465600 N1465900 N1466100 N1815200 N1815600 N1815700 N1816200 N1816300 N3155800 N3155900 N3156000 N3156100 N3156200 N3156300 N3156400 N3156500 N3156600 N3156800 N3157000 N3663100 N3663300 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 AU2700 OPA, Item Code: 5996100 N3156700 N9025844 AU5400 OPA, Item Code: 6196400 6196500 6196700 N1257900 N1258000 N3666000 N3877100 N3877200 N3877300 N3877600 N3877700
Product Distributed Qty 4584 units total (1173 units in US)
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.

Event Detail

Event Id 66253
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.