Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. |
|---|---|
| Recall Number | Z-2066-2012 |
| Classification | Class II |
| Code Info | Version 2.6.1 & Below |
| Product Distributed Qty | 2044 |
| Reason For Recall | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment. |
Event Detail
| Event Id | 61910 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Ortho-Clinical Diagnostics |
| City | Rochester |
| State | NY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-21 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal. |
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