Class 2 Device Recall IDSiSYS Intact PINP

• Date Initiated by Firm: August 10, 2012
• Date Posted: October 10, 2012
• Recall Status: Terminated on December 17, 2012
• Recall Number: Z-0044-2013
• Recall Event ID: 62968
• Product Classification: N/A - Product Code CIN
• Product: 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.
• Code Information: Lot 1170, EXP Feb 2013
• Recalling Firm/ Manufacturer: Immunodiagnostics Systems Ltd; 10 Didcot Way Bolden Business Park; Boldon Tyne & Wear United Kingdom
• Manufacturer 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.
• FDA Determined Cause: Labeling False and Misleading
• Action: Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately. 2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return. 3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office. Contact information was also provided. For questions regarding this recall call +44 (191) 5195212.
• Quantity in Commerce: 10
• Distribution: Nationwide Distribution including NY, CA, ME and CT.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.