IDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling
Immunodiagnostics Systems Ltd is recalling IDS Urine BETA CrossLaps ELISA kits 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 FDA Class II, but the source text explicitly states no illnesses or injuries were reported. The hazard is a labeling error regarding regulatory status (IVD vs. Research Use Only), which fits the rubric for moderate severity involving labeling issues without reported harm.
Plain-English summary
Immunodiagnostics Systems Ltd is recalling one lot of the IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. The affected product is an enzyme immunological test intended for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The specific lot number is 14541, with an expiration date of November 2012.
The recall was initiated because staff at IDS Inc. noted that the stock of these products 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 indicates that the products should have been labeled as Research Use Only or Investigational use only, depending on their specific usage.
The affected products were distributed nationwide, including in New York, California, Maine, and Connecticut. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these products. Consumers and healthcare facilities should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in…
- Manufacturer
- Immunodiagnostics Systems Ltd
- Hazard
- Affected units
- 1
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 14541
- EXP Nov 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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