FDA-Device2012-10-17Class II
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.
Immunodiagnostics Systems Ltd
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.
Sold states
Nationwide Distribution including NY, CA, ME and CT.
Affected count
5
Manufactured in
10 Didcot Way Bolden Business Park, N/A, Boldon Tyne & Wear, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0043-2013Don't want to check this manually?
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