R&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits
R&D Systems is recalling 156 Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls.
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 source text describes a functional defect (low signal/out-of-spec controls) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
R&D Systems, Inc. is recalling 156 units of the Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit). This enzyme-linked immunosorbent assay (ELISA) is used for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma to aid in the diagnosis of anemia and polycythemia.
The recall was initiated after the manufacturer received two complaints indicating that the standard signal was low and that the controls were not within the specification range provided with the kit. An investigation confirmed that the low standard signal and out-of-specification controls were present in both the kits returned by the customer and the retained kits.
The affected kits were distributed in the United States (Florida, Louisiana, California, Ohio), China, the United Kingdom, Japan, Singapore, and Jakarta Selatan. The specific lot numbers involved are P252478, P263156, P256349, P263160, and P264604. Users of these kits should stop using them and contact R&D Systems, Inc. for further instructions.
The recalled product
- Product
- Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the…
- Manufacturer
- R & D Systems, Inc.
- Affected units
- 156
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 (7)
- Catalog #: DTFR1
- Unique Device Identification (UDI) #: 815762021657
- Lot #: P252478
- P263156
- P256349
- P263160
- P264604
Distribution
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