Helena Laboratories Recalls Mislabeled Protein S ELISA Antigen Kits
Helena Laboratories is recalling three Protein S ELISA Antigen Kits because internal components were mislabeled, causing the Substrate and Protein S Conjugate to be swapped.
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, and the hazard involves minor labeling errors on internal components of a diagnostic kit without reported injuries or illnesses.
Plain-English summary
Helena Laboratories, Inc. is recalling three units of the "Free and Total Protein S ELISA Kit" (Catalog No. 5292, Lot 3-16-5292). The recall was initiated because the internal components of the kits were mislabeled. Specifically, the Protein S Conjugate Solution was labeled as Substrate, and the Substrate was labeled as Protein S conjugate.
The affected kits were distributed internationally to Jordan. The kits are intended for in-vitro diagnostic use to quantify free and total Protein antigen in citrated human plasma. The mislabeling involves the outer labeling of the Substrate and Protein S Conjugate bottles, which contain the same expiration date and lot information but are identified with the wrong product names.
Users of these kits should stop using the affected components and contact Helena Laboratories for further instructions. The recall is limited to the three specific kits identified by the lot number and catalog number provided in the agency's notice.
The recalled product
- Product
- "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent…
- Manufacturer
- Helena Laboratories, Inc.
- 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)
- 3-16-5292
- UDI: Primary DI - M52552920
Distribution
Distribution scope not specified by the agency.
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