R & D Systems, Inc. recalls
Every recall we track for R & D Systems, Inc. — 5 in all, from 2018–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
5 recalls since 2017.
All FDA recall records for R & D Systems, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled R & D Systems, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All R & D Systems, Inc. recalls
5 shown- Lower riskMedical device
R & D Systems, Inc. recalls R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;
R&D Systems recalls CBC-3D Hematology Controls (lot B1122) with potential microbial contamination causing hemolysis. Affected products include various control kits for hematology analyzers.
R&D SystemsNov 7, 2022 - Lower riskMedical device
R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of
R&D Systems recalls Quantikine Erythropoietin Human Serum Controls due to incorrect CE marking in product instructions. Affected lots have a labeling error that may cause regulatory issues but does not pose a safety risk to users.
R&D SystemsJun 14, 2022 - Lower riskMedical device
R & D Systems, Inc. recalls Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked
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 SystemsJan 20, 2021 - Lower riskMedical device
R & D Systems, Inc. recalls Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked
R&D Systems recalls Quantikine sTfR ELISA Kit (catalog DTFR1, lot P180851) due to incorrect control data card number. This may affect lab results accuracy for iron deficiency anemia testing.
R&D SystemsNov 1, 2018 - Lower riskMedical device
R & D Systems, Inc. recalls R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
R&D Systems recalls Human Total 25-OH Vitamin D IVD ELISA Kit (REF RDKAP1971) due to missing lot-specific manual and incorrect reconstitution volume label. Affected units sold with Manufacturing Lot # 182801.
R&D SystemsSep 11, 2018
R & D Systems, Inc. recall questions
How many recalls has R & D Systems, Inc. had?
5 recalls from R & D Systems, Inc. are on record with U.S. safety agencies, from 2018–2022.
What is the most recent R & D Systems, Inc. recall?
R & D Systems, Inc. recalls R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;, dated Nov 7, 2022. Every R & D Systems, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled R & D Systems, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new R & D Systems, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.