Recall Z-0040-2013 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Immunodiagnostics Systems Ltd
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
| Date | Oct 10, 2012 (initiated Aug 10, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediatel |
| Quantity | 3 |
| Distribution | Nationwide Distribution including NY, CA, ME and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.