IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin 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 assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
Enforcement
- Recall Number
- Z-0042-2013
- 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 N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin 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 assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
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 948 and 1145, EXP Aug 2012 and Jan 2013 respectively
Nationwide Distribution including NY, CA, ME and CT.
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