R&D Systems Recalls Quantikine IVD sTfR Immunoassay Kits Due to Control Issues
R&D Systems is recalling 725 Quantikine IVD sTfR Immunoassay Kits because internal testing confirmed that control results were out of range high.
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 does not report any illnesses, injuries, or hospitalizations. The hazard is limited to potential inaccurate test results due to out-of-range controls, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/quality issues without reported harm.
Plain-English summary
R&D Systems, Inc. is recalling 725 units of the Quantikine IVD sTfR Immunoassay Kit, REF DTFR1. This product is used for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma for in vitro diagnostic use.
The recall was initiated after R&D Systems received two customer complaints indicating that the results of the controls provided with the kits were out of range high. Internal testing by the manufacturer confirmed that the control results were indeed out of range high.
The affected kits were distributed in the United States (California, Colorado, Kentucky, Louisiana, Maryland, Massachusetts, New Jersey, Ohio, Rhode Island, Utah, Virginia, and Washington) and internationally (Australia, China, India, Indonesia, Israel, Japan, Mexico, South Korea, and the United Kingdom). Affected lot codes include 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, and 340362. Users should stop using the affected kits and contact R&D Systems for instructions.
The recalled product
- Product
- R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
- Manufacturer
- R & D Systems, Inc.
- Hazard
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 (11)
- 331636
- 331637
- 332060
- 332090
- 332924
- 334184
- 335062
- 335740
- 336694
- 339307
- 340362.
Distribution
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