R & D Systems, Inc.
FDA Regulatory Profile
R & D Systems, Inc. appears in FDA public data with 6 recalls, 79 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0999-2023, Class III) was initiated on November 7, 2022. Its most recent 510(k) clearance was granted on September 1, 2016.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 79
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0999-2023 | Class III | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 1 | November 7, 2022 |
| Z-1390-2022 | Class III | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determin | June 14, 2022 |
| Z-1255-2021 | Class II | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system) | January 20, 2021 |
| Z-0691-2019 | Class III | Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR E | November 1, 2018 |
| Z-0410-2019 | Class III | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 | September 11, 2018 |
| Z-2887-2016 | Class II | R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble tra | August 24, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160606 | BC-5D Hematology Control | September 1, 2016 |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | July 24, 2013 |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | April 28, 2011 |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | January 29, 2010 |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | October 28, 2009 |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | December 27, 2007 |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | November 26, 2007 |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | November 20, 2007 |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | August 20, 2007 |
| K070334 | R&D SICKLE QC CONTROL | March 29, 2007 |
| K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | July 10, 2006 |
| K061320 | R&D LH-NRBC HEMATOLOGY CONTROL | June 2, 2006 |
| K051339 | R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL | July 12, 2005 |
| K042094 | R&D CBC-XE HEMATOLOGY CONTROL | September 1, 2004 |
| K034048 | R&D GLU-LINE HEMATOLOGY CONTROL | March 10, 2004 |
| K020229 | R & D BODY FLUID CONTROL | February 6, 2002 |
| K013898 | R&D RET-LINE KIT | January 22, 2002 |
| K010470 | R & D 4K RETIC | May 11, 2001 |
| K010461 | ADVIA RETIC PLUS | April 3, 2001 |
| K010409 | CBC-SF | March 16, 2001 |