Recall Register

Food, drugs, devices › Firms

R & D Systems, Inc.

FDA recalling firm · 6 enforcement events · 6 product records · 2016–2022 · MN

R & D Systems, Inc. has 6 FDA enforcement events on this register (6 product records) between 2016 and 2022: 6 device; the busiest year was 2018 with 2.

0% of its events are Class I; the most common class is Class III (4). 0 events are listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
7 Nov 2022R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and…DeviceClass III1Terminated
14 Jun 2022Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095DeviceClass III1Terminated
20 Jan 2021Quantikine 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 diagnosis of anemia and polycythemia.DeviceClass II1Terminated
1 Nov 2018Quantikine¿ 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 the differential diagnosis of iron deficiency…DeviceClass III1Terminated
11 Sep 2018R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971DeviceClass III1Terminated
24 Aug 2016R&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.DeviceClass II1Terminated

By type and class

Device6
Class III4
Class II2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

16
17
18
19
20
21
22
23
24
25
26
Enforcement events for R & D Systems, Inc. by year initiated.

Questions and answers

How many FDA recalls has R & D Systems, Inc. had?

6 enforcement events (6 product records) on this register, 2016–2022: 6 device.

Are any R & D Systems, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are R & D Systems, Inc. recalls?

4 Class III, 2 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.