IDS-iSYS Intact PINP — Class II medical device recall Z-0044-2013
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-0044-2013 |
|---|---|
| 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 | 10 |
| Reason classes | labeling |
| Lot numbers | 1170 |
| Model numbers | IS-4000 |
| Expiration dates | 2013-02-20 |
Product
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
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-0044-2013. 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.