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. |
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