FDAFDA · Food and drugs·Recall number Z-0040-2013
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.
Published October 17, 2012 · Recall initiated: August 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Immunodiagnostics Systems Ltd
- Distributor
- Nationwide Distribution including NY, CA, ME and CT.
- Lot
- Lot 1184, EXP Aug 2012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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