Facility

R & D SYSTEMS, INC.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2182501
Establishment type	Manufacture Medical Device
Location	614 Mckinley Pl Ne MINNEAPOLIS, MN, US 55413
Registration status	Active · expires 2026
Parent company	R & D SYSTEMS, INC. (owner-operator 2182501)
Brand names	Leuko-Reduced RBC Control

Activity by year

Recalls (6)

Devices registered here (1)

Counter, Differential Cell
Product code GKZ (opens in a new tab) · Class II · Hematology · 21 CFR 864.5220

Recalls & enforcement

Class IIITerminated2022-11-07
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
Class IIITerminated2022-06-14
The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-279…
Class IITerminated2021-01-20
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…
Class IIITerminated2018-11-01
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Class IIITerminated2018-09-11
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.
Class IITerminated2016-08-24
R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine® IVD® Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.

All facilities operated by R & D SYSTEMS, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “R & D SYSTEMS, INC. (FEI 2182501) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2182501-r-d-systems-inc/

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