Device product
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Z-0043-2013
Product summary
- Event
- Event 62968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0043-2013
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 958, EXP Sep 2012
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.