IDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling
Immunodiagnostics Systems Ltd is recalling 29 units of IDS-iSYS Intact PINP Control Set because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use 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: This is a labeling error where products were marked as IVDs without proper registration. The rubric classifies minor labeling errors as Moderate severity (Score 2).
Plain-English summary
Immunodiagnostics Systems Ltd is recalling 29 units of the IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. The affected products are packaged in cardboard boxes containing plastic bottles and are used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
The recall was initiated after staff at IDS Inc. noted that the stock held at their facility was labeled with In Vitro Diagnostic (IVD) labels. However, these products are not registered for sale as IVDs in the United States. The source text indicates that the products should have been labeled as Research Use Only or Investigational use only, depending on their specific usage.
The affected units are identified by Lot 975 with an expiration date of September 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 recalling firm for further instructions.
The recalled product
- Product
- IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the…
- Manufacturer
- Immunodiagnostics Systems Ltd
- Hazard
- Affected units
- 29
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 975
- 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.
See all 7 products in this recall →Related recalls
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