Device 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.
Z-0044-2013
Product summary
- Event
- Event 62968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-0044-2013
Official wording
Reason: 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.
Code information: Lot 1170, EXP Feb 2013
Distribution pattern: Nationwide Distribution including NY, CA, ME and CT.
Derived failure modes
-
Unknown
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.