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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Event Detail

Event ID 63020
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 2012-08-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MicroCel 500 Buffer Chamber Mfg by: Siemens Healthcare Diagnostics Inc., Berkeley, CA. Catalog number 10312319/VG 42115 Product will have the letter R after the manufacture date. Class II Trugene MicroCel 500 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. 1 Unit B-2519-12