R&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card
R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging/documentation error (incorrect control card) rather than a product defect causing harm.
Plain-English summary
R&D Systems, Inc. is recalling 198 units of the Human sTfR Quantikine IVD ELISA Kit, catalog number DTFR1, lot number P180151. The recall is due to a packaging error where the kits were packed with the incorrect control data card number 750228.4.
The affected kits were distributed nationwide in the United States and internationally to Japan, Mexico, South Korea, and the United Kingdom. The product is an immunoassay kit intended for the measurement of soluble transferrin receptor (sTfR) concentration in human serum or plasma to aid in the diagnosis of iron deficiency anemia.
Consumers and laboratories should stop using the affected kits and contact R&D Systems, Inc. for instructions on return or replacement. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially…
- Manufacturer
- R & D Systems, Inc.
- Hazard
- Affected units
- 198
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)
- Catalog number DTFR1
- Lot number P180851
Distribution
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