Immunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error
Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP assays because they were labeled for in vitro diagnostic use despite not being 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 minor labeling error regarding regulatory status (IVD vs. Research Use Only) without reported injuries or illnesses, fitting the criteria for low-risk contamination or labeling issues.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling three units of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) assay, Catalog Number IS-2800. The affected product is Lot 1184 with an expiration date of August 2012. The product was distributed nationwide, including in New York, California, Maine, and Connecticut.
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.
This recall involves a labeling discrepancy regarding the regulatory status of the medical device. No specific instructions for consumers are provided in the source text beyond the identification of the labeling error.
The recalled product
- Product
- IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator…
- 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 1184
- 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.
See all 7 products in this recall →Related recalls
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