FDA Device recall Z-0042-2013
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900
- FDA Device
- Class II
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class II recall of IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900 by Immunodiagnostics Systems, citing 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 Un….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0042-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-10 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Immunodiagnostics Systems |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0042-2013%22
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