Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser. |
|---|---|
| Recall Number | Z-0044-2013 |
| Classification | Class II |
| Code Info | Lot 1170, EXP Feb 2013 |
| Product Distributed Qty | 10 |
| 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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