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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. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Recall Number Z-0153-2014
Classification Class II
Code Info AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500 AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900 AU680 OPA: B11474 N3148300 N3148600 N3148700 N3150500 N3912700 AU5800 OPA, Item Code: A94927 A94928 A94929 A94930 N9028030
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.