Z-0041-2013 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
- 3
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.
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 1177, EXP Aug 2012