C-Peptide ELISA Kit Recalled Due to Defective Standards
DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a diagnostic test kit with a technical defect that may produce invalid test results and delay patient results. No illnesses or injuries have been reported, and the hazard is theoretical; therefore, it is classified as High rather than Severe.
Plain-English summary
DRG International, Inc. is recalling its C-Peptide ELISA (Catalog # EIA-1293), a diagnostic test used to measure C-Peptide levels in blood and urine samples. The recall was initiated because the optical density (OD) of the standards in the kit was found to be too low—below the required 0.6 ODmax threshold. This defect can cause invalid test runs and may delay patient results.
The affected lots are: - Lot # 20K061 (expires June 30, 2022) - Lot # 20K071 (expires July 31, 2022) - Lot # 20K081 (expires August 31, 2022)
The kits were distributed in New York. Laboratories that received this product should verify their inventory against the lot numbers listed above.
The recalled product
- Product
- C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
- Manufacturer
- DRG International, Inc.
- Affected units
- 3
Distribution
Distributed in 1 state:
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