R & D Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
79
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0999-2023Class IIIR&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 1November 7, 2022
Z-1390-2022Class IIIQuantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determinJune 14, 2022
Z-1255-2021Class IIQuantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)January 20, 2021
Z-0691-2019Class IIIQuantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR ENovember 1, 2018
Z-0410-2019Class IIIR&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971September 11, 2018
Z-2887-2016Class IIR&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble traAugust 24, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K160606BC-5D Hematology ControlSeptember 1, 2016
K130962R&D 5D RETIC HEMATOLOGY CONTROLJuly 24, 2013
K101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLApril 28, 2011
K100050R & D SYSTEMS XERET HEMATOLOGY CONTROLJanuary 29, 2010
K091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLOctober 28, 2009
K073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004December 27, 2007
K072846CSF AUTOMATED CONTROL, MODELS CSF001, CSF003November 26, 2007
K072268HC WBC HEMATOLOGY CONTROL, MODEL: WBC00SNovember 20, 2007
K072096CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04August 20, 2007
K070334R&D SICKLE QC CONTROLMarch 29, 2007
K061511R&D CBC-3D + CRP HEMATOLOGY CONTROLJuly 10, 2006
K061320R&D LH-NRBC HEMATOLOGY CONTROLJune 2, 2006
K051339R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROLJuly 12, 2005
K042094R&D CBC-XE HEMATOLOGY CONTROLSeptember 1, 2004
K034048R&D GLU-LINE HEMATOLOGY CONTROLMarch 10, 2004
K020229R & D BODY FLUID CONTROLFebruary 6, 2002
K013898R&D RET-LINE KITJanuary 22, 2002
K010470R & D 4K RETICMay 11, 2001
K010461ADVIA RETIC PLUSApril 3, 2001
K010409CBC-SFMarch 16, 2001