Product Description
IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteocalcin 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 assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
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.
Action Details
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 immediately.
2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return.
3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office.
Contact information was also provided.
For questions regarding this recall call +44 (191) 5195212.
Distribution Pattern
Nationwide Distribution including NY, CA, ME and CT.
Code Information / Serial Numbers
Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.