IDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors
Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin Control Sets because they were labeled as IVDs instead of Research Use Only.
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 Moderate because it involves a minor labeling error where products were not registered for their intended sale status, with no reported injuries or illnesses.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling five units of the IDS-iSYS N-Mid Osteocalcin Control Set, Catalog Number IS-2930. The affected products are identified by Lot 958 and an expiration date of September 2012. These control sets are used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
The recall was initiated because 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 products were distributed nationwide, including in New York, California, Maine, and Connecticut. Consumers and healthcare facilities should stop using the affected control sets and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
- 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 958
- EXP Sep 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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