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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

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

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 Letter
Distribution Pattern Nationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil.