Z-0044-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2012
- Initiation Date
- August 10, 2012
- Termination Date
- December 17, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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.
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.
Distribution Pattern
Nationwide Distribution including NY, CA, ME and CT.
Code Information
Lot 1170, EXP Feb 2013