IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling
Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding regulatory status (IVD vs. Research Use Only) rather than a direct physical or chemical hazard causing injury.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. The affected product is packaged in a cardboard box containing plastic bottles and is used for quality control of the IDS-iSYS Ostase BAP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
The recall was initiated because staff at IDS Inc. noted that the stock is labeled with IVD (In Vitro Diagnostic) labels, although the products 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, depending on their usage.
The recall involves Lot 1177 with an expiration date of August 2012. The products were distributed nationwide, including in New York, California, Maine, and Connecticut. Users should stop using the affected control sets and contact the manufacturer for further instructions.
The recalled product
- Product
- IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Ass
- Manufacturer
- Immunodiagnostics Systems Ltd
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1177
- EXP Aug 2012
Distribution
Part of a larger recall action
This product is one of 7 recalled by Immunodiagnostics Systems Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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