IDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling
Immunodiagnostics Systems Ltd is recalling IDS-iSYS Intact PINP assays because they were labeled for In Vitro Diagnostic use but are not registered for that purpose in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 labeling error where the product was not registered for its labeled use, fitting the rubric criteria for minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling 10 units of the IDS-iSYS Intact PINP assay, Catalog Number IS-4000, Lot 1170, with an expiration date of February 2013. The product is packaged in a cardboard box containing plastic bottles and is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
The recall was initiated because staff at IDS Inc. noted that the stock of affected products held at IDS Inc. is labeled with In Vitro Diagnostic (IVD) labels. However, these 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. The source text does not specify specific actions for consumers or healthcare providers beyond the identification of the mislabeled stock.
The recalled product
- Product
- 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…
- Manufacturer
- Immunodiagnostics Systems Ltd
- Hazard
- Affected units
- 10
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 1170
- EXP Feb 2013
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.
See all 7 products in this recall →Related recalls
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