Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) 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 Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, 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 aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
Quantity: 3
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