R&D Systems recalls Quantikine Human sTf:R ELISA Kit due to low signal and out-of-specification controls. Affected kits may not provide accurate anemia/polycythemia test results.
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.
R&D Systems is recalling Quantikine Human sTfR ELISA Kits because they produce low signal and out-of-specification controls, which could lead to inaccurate anemia or polycythemia test results. This affects kits with specific lot numbers and catalog codes.
The kit's standard signal is too low and controls fall outside the specified range, meaning test results for anemia and polycythemia could be inaccurate. This happens because the kit doesn't function properly as intended.
Researchers and medical professionals using the Quantikine sTfR ELISA Kit for blood tests may be affected. Those testing for anemia or polycythemia are most at risk if the kit provides inaccurate results.
Check for the catalog number DTFR1 and lot numbers P252478, P263156, P256349, P263160, or P264604. The kit is sold as an enzyme-linked immunosorbent assay for human serum and plasma testing.
Verify if your kit has lot numbers P252478, P263156, P256349, P263160, or P264604.
R&D Systems received complaints that the standard signal was low and controls were out of specification, leading to inaccurate test results for anemia and polycythemia.
Check your kit's lot number against the listed numbers (P252478, P263156, P256349, P263160, P264604). If it matches, contact R&D Systems for guidance.
The recall record does not mention a remedy or fix; affected kits may need to be replaced or discarded.
We’ve drafted a message you can send R&D Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1255-2021 — R&D Systems R&D Systems Hello, I own a R&D Systems that is covered by recall Z-1255-2021 from R&D Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
