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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64773
Product Type Biologics
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics Inc.
City Berkeley
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US and Belgium, France, Greece, Italy, Portugal, Spain, Germany, Kenya, Martinique, Austria, Brazil, Canada, Czech Republic, Guadeloupe, Ireland, Israel, Kuwait, Latvia, Mexico, Panama, Peru, Saudi Arabia, Thailand, UK, Uruguay, Vietnam

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MicroCel 500 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710 Catalog number 10312319/VG 42115 Class II MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. 1 B-1448-13
MicroCel 300 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710 Catalog number 10319937/ VG 42044 Class II MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. 1 B-1449-13
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