Food, drugs, devices › R & D Systems, Inc.
Device recall: R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
R & D Systems, Inc. (Minneapolis, MN) initiated this device recall on 11 Sep 2018; FDA lists 1 product record under event 81121, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 1 Sep 2020. Initiation: voluntary: firm initiated. R & D Systems, Inc. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
R & D Systems, Inc., Minneapolis, MN.
Reason for recall
"The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL."
Distribution
"IA and CO"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0410-2019 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 | 8 kits | Class III | Terminated | 14 Nov 2018 |
Context
Other enforcement events for R & D Systems, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Nov 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2 | Device | Class III | 1 |
| 14 Jun 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoie | Device | Class III | 1 |
| 20 Jan 2021 | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked | Device | Class II | 1 |
| 1 Nov 2018 | Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbe | Device | Class III | 1 |
| 24 Aug 2016 | R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (s | Device | Class II | 1 |
All 6 events for R & D Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "IA and CO"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Sep 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.