Immunodiagnostics Systems Ltd: Medical Device Recall in 2012 - (Recall #: Z-0042-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 10, 2012

Date Posted: October 17, 2012

Recall Number: Z-0042-2013

Event ID: 62968

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.

Status: Terminated

Product Quantity: 5

Code Information:

Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively

Distribution Pattern:

Nationwide Distribution including NY, CA, ME and CT.

Voluntary or Mandated:

Voluntary: Firm initiated