Recall Z-0041-2013— Immunodiagnostics Systems Ltd
Class II · Terminated
Class II FDA medical device recall by Immunodiagnostics Systems Ltd, initiated 2012-08-10, terminated 2012-12-17. FDA's recall record names no specific 510(k) clearance for this event. Product: IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.. Reason: 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..
- Recalling firm
- Immunodiagnostics Systems Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-10
- Terminated
- 2012-12-17
- Firm location
- Boldon Tyne & Wear, N/A, United Kingdom
Product description
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.