IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
Enforcement
- Recall Number
- Z-0040-2013
- Event ID
- 62968
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Immunodiagnostics Systems Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- October 17, 2012
- Initiation Date
- August 10, 2012
- Classification Date
- October 10, 2012
- Termination Date
- December 17, 2012
- Address
- 10 Didcot Way Bolden Business Park, N/A, Boldon Tyne & Wear, N/A, N/A, United Kingdom
Description
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
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.
Lot 1184, EXP Aug 2012
Nationwide Distribution including NY, CA, ME and CT.
3