Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase® BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease. |
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| Recall Number | Z-0040-2013 |
| Classification | Class II |
| Code Info | Lot 1184, 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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