FDAFDA · Food and drugs·Recall number Z-0043-2013
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.
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 958, EXP Sep 2012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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