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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. 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 Class II 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. 4584 units total (1173 units in US) Z-0153-2014
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. 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 Class II 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. 4584 units total (1173 units in US) Z-0152-2014
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