IDS-iSYS Osteocalcin Assay Recalled for Incorrect IVD Labeling
Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin assays because they were labeled as In Vitro Diagnostics (IVD) despite not being 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: This is a Class II recall involving a labeling error where products were not registered for their labeled use, fitting the criterion for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling five units of the IDS-iSYS N-Mid Osteocalcin Assay, Catalog Number IS-2900. The affected products are packaged in cardboard boxes containing plastic bottles and are intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
The recall was initiated after staff at IDS Inc. noted that the stock was labeled with In Vitro Diagnostic (IVD) labels. However, the products are not registered for sale as IVDs in the United States. The source text states that the products should have been labeled as Research Use Only or Investigational use only, depending on their usage.
The affected lots are 948 and 1145, with expiration dates of August 2012 and January 2013, respectively. The products were distributed nationwide, including in New York, California, Maine, and Connecticut. Users should verify their product labels and contact the manufacturer for further instructions regarding the correct usage classification.
The recalled product
- 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 Anal
- Manufacturer
- Immunodiagnostics Systems Ltd
- Hazard
- Affected units
- 5
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 948 and 1145
- EXP Aug 2012 and Jan 2013 respectively
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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