IDS-iSYS N-Mid¿ Osteocalcin — Class II medical device recall Z-0042-2013
Terminated recall by Immunodiagnostics Systems Ltd, reported 2012-10-17, distributed nationwide. It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with I
| Recall number | Z-0042-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immunodiagnostics Systems Ltd, Boldon Tyne & Wear, N/A, United Kingdom |
| Recall initiated | 2012-08-10 |
| Classified | 2012-10-10 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2012-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Reason classes | labeling |
| Lot numbers | 1145, 948 |
| Model numbers | IS-2900 |
| Expiration dates | 2012-08-20 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0042-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.