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U.S. Department of Health and Human Services

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.
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
Country GB
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-10
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution including NY, CA, ME and CT.