Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | ORTHO-ProVue (TM) A modular, microprocessor-controled instrument. |
|---|---|
| Recall Number | B-2373-12 |
| Classification | Class II |
| Code Info | MTS213784 |
| Product Distributed Qty | 1 unit |
| Reason For Recall | ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed. |
Event Detail
| Event Id | 32594 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Micro Typing Systems Inc. |
| City | Pompano Beach |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2004-07-08 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | The product was distributed to 79 consignees throughout the USA and Canada. |
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