Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase® BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser. |
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| Recall Number | Z-0041-2013 |
| Classification | Class II |
| Code Info | Lot 1177, EXP Aug 2012 |
| Product Distributed Qty | 3 |
| Reason For Recall | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. |
Event Detail
| Event Id | 62968 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Immunodiagnostics Systems Ltd |
| City | Boldon Tyne & Wear |
| State | Country | GB |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-10 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide Distribution including NY, CA, ME and CT. |
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