Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IDS-iSYS Intact PINP Recalled by Immunodiagnostics Systems Ltd Due to It has been noted by staff at IDS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Immunodiagnostics Systems Ltd directly.
Affected Products
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.
Quantity: 10
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Immunodiagnostics Systems Ltd
Immunodiagnostics Systems Ltd has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report