System, Test, Rheumatoid Factor
FDA product code DHR · Class II (moderate risk) · 21 CFR 866.5775 · Immunology
144510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Behring Diagnostics, Inc. 5
- Inova Diagnostics, Inc. 4
- Kamiya Biomedical Co. 4
- Beckman Instruments, Inc. 4
- Bd Becton Dickinson Vacutainer Systems Preanalytic 3
- Immunostics Inc., 3
- Texas Immunology, Inc. 3
- Diamedix Corp. 3
- Kallestad Diag, A Div. of Erbamont, Inc. 3
- Abbott Laboratories 3
- Cogent Diagnotics , Ltd. 3
- Biokit USA, Inc. 3
- Zeus Scientific, Inc. 3
- Bio-Rad 3
- Roche Diagnostics Corp. 3
- Theratest Laboratories, Inc. 3
- Scripps-Miles, Inc. 2
- Armkel, LLC 2
- Biosearch Medical Products, Inc. 2
- Wako Chemicals USA, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | Kamiya Biomedical Company | 05/20/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | Inova Diagnostics, Inc. | 04/17/2019SE |
| K182747 | EliA RF IgM ImmunoassayDHR · Traditional | Phadia AB | 12/18/2018SE |
| K162263 | Optilite Rheumatoid Factor KitDHR · Traditional | The Binding Site Group , Ltd. | 05/03/2017SE |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR · Traditional | The Binding Site Group , Ltd. | 12/07/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | Immco Diagnostics, Inc. | 09/23/2015SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | Phadia US, Inc. | 09/30/2011SE |
| K100499 | Orgentec Rheumatoid Factor EiaDHR · Traditional | Orgentec Diagnostika GmbH | 10/27/2010SE |
| K083080 | Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics PlatformDHR · Traditional | Sqi Diagnostics Systems | 10/29/2009SE |
| K071247 | N Latex RF KitDHR · Traditional | Dade Behring, Inc. | 08/08/2007SE |
| K060201 | Olympus RF Latex Calibrator, and Olympus RF Latex Reagent with Model(S): ODC0028, and…DHR · Traditional | Olympus America, Inc. | 06/06/2006SE |
| K041891 | Minineph Human Rheumatoid Factor KitDHR · Traditional | The Binding Site | 11/05/2004SE |
| K041863 | Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16…DHR · Traditional | Ortho-Clinical Diagnostics, Inc. | 09/20/2004SE |
| K033802 | Athena Multi-Lite Rheumatoid Factor Igm Test SystemDHR · Traditional | Zeus Scientific, Inc. | 02/27/2004SE |
| K032535 | Modification To:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemDHR · Special | Roche Diagnostics Corp. | 09/10/2003SE |
| K024067 | Rheumatoid Factor (RF)DHR · Traditional | Abbott Laboratories | 01/15/2003SE |
| K020972 | Wako Rf-Ha (2), RF Calibrator, RF Calibrator SetDHR · Traditional | Wako Chemicals USA, Inc. | 09/09/2002SE |
| K021394 | Diamedix Is-Rheumatoid Factor Test SystemDHR · Traditional | Diamedix Corp. | 07/09/2002SE |
| K002609 | Tina-Quant Rheumatoid Factors II Test SystemDHR · Traditional | Roche Diagnostics Corp. | 09/05/2000SE |
| K000534 | Cobas Integra Reagent Cassette for Rheumatoid Factor IIDHR · Traditional | Roche Diagnostics Corp. | 04/05/2000SE |
| K993557 | Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional | Cogent Diagnotics , Ltd. | 03/03/2000SE |
| K994338 | Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional | Cogent Diagnotics , Ltd. | 02/03/2000SE |
| K993843 | Mdi RF TestDHR · Traditional | Micro Detect, Inc. | 01/11/2000SE |
| K993304 | Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional | Cogent Diagnotics , Ltd. | 12/06/1999SE |
| K991467 | K-Assay Rheumatoid Factor Calibrator SetDHR · Traditional | Kamiya Biomedical Co. | 06/10/1999SE |
| K991409 | K-Assay Rheumatoid FactorDHR · Traditional | Kamiya Biomedical Co. | 06/09/1999SE |
| K990587 | Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01DHR · Traditional | Bio-Rad | 04/07/1999SE |
| K990035 | RFDHR · Traditional | Abbott Laboratories | 03/08/1999SE |
| K984045 | RF Control for Immunoturbidimetric AssaysDHR · Traditional | Kamiya Biomedical Co. | 01/25/1999SE |
| K983418 | The Aptus(Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an…DHR · Traditional | Zeus Scientific, Inc. | 11/18/1998SE |
| K983084 | Quanta Lite RF Iga ElisaDHR · Traditional | Inova Diagnostics, Inc. | 11/04/1998SE |
| K983083 | Quanta Lite RF Igg ElisaDHR · Traditional | Inova Diagnostics, Inc. | 11/04/1998SE |
| K981496 | Color-Slide RFDHR · Traditional | Seradyn, Inc. | 06/15/1998SE |
| K974889 | Diamedix Is-Rf Test SystemDHR · Traditional | Diamedix Corp. | 03/06/1998SE |
| K974370 | Rapet RFDHR · Traditional | Stanbio Laboratory | 02/17/1998SE |
| K972456 | Rheumacol Rheumatoid Factor TestDHR · Traditional | Immunostics Inc., | 11/25/1997SE |
| K973464 | Quantex RF Plus (Latex, Buffer, Standard, Control)DHR · Traditional | Instrumentation Laboratory CO | 10/22/1997SE |
| K972220 | Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test KitDHR · Traditional | Randox Laboratories, Ltd. | 09/09/1997SE |
| K971602 | Array Systems Rheumatoid Factor (Rfmpe) ReagentDHR · Traditional | Beckman Instruments, Inc. | 06/27/1997SE |
| K971614 | Quanta Lite RF IgmDHR · Traditional | Inova Diagnostics, Inc. | 06/20/1997SE |
| K971379 | Tinaquant Rheumatoid Factor AssayDHR · Traditional | Boehringer Mannheim Corp. | 06/17/1997SE |
| K971788 | Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF CalibratorDHR · Traditional | Beckman Instruments, Inc. | 06/03/1997SE |
| K970373 | Raichem Rheumatoid Factor SpiaDHR · Traditional | Henage Diagnostics, Inc. | 04/17/1997SE |
| K962729 | Hycor Hy.Tec/Manual RF Auto-AntibodyDHR · Traditional | Hycor Biomedical, Inc. | 03/07/1997SE |
| K962050 | Theratest El-RfscrDHR · Traditional | Theratest Laboratories, Inc. | 12/16/1996SE |
| K964418 | N-Assay Tia Rheumatoid Facotr Multi-Calibrator SetDHR · Traditional | Kamiya Technology Services | 12/13/1996SE |
| K964415 | N-Assay Tia Rheumatoid Factor Test KitDHR · Traditional | Kamiya Technology Services | 12/13/1996SE |
| K962015 | Rheumatoid Factor (RF) Reagenti a Latex Slide TestDHR · Traditional | Teco Diagnostics | 11/25/1996SE |
| K963048 | Immage System Rheumatoid Factor (RF) ReagentDHR · Traditional | Beckman Instruments, Inc. | 11/04/1996SE |
| K961545 | Qualitrol RF ControlsDHR · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
| K962836 | Hemagen Rheumatoid Factor Kit (Eia Method)DHR · Traditional | Hemagen Diagnostics, Inc. | 09/12/1996SE |
| K961169 | Rheumatoid Factor Latex Slide Test KitDHR · Traditional | Randox Laboratories, Ltd. | 06/26/1996SE |
| K960987 | Liquichek Rheumatoid Factor ControlDHR · Traditional | Bio-Rad | 06/04/1996SE |
| K961277 | RF Igm Elisa Test SystemDHR · Traditional | Zeus Scientific, Inc. | 05/08/1996SE |
| K960703 | Rf-Latex Seiken Reagent SystemDHR · Traditional | Globe Management Support, Inc. | 04/19/1996SE |
| K954892 | Hytec Automimmune Kit (RF)DHR · Traditional | Hycor Biomedical, Inc. | 12/26/1995SE |
| K955086 | Test, Rheumatoid FactorDHR · Traditional | Polymedco, Inc. | 12/20/1995SE |
| K953520 | Olympus Rheumatoid Factor Immunoturbidimetric ReagentDHR · Traditional | Olympus America, Inc. | 08/24/1995SE |
| K953261 | Chromalex Rheumatoid Factor Latex Test SystemDHR · Traditional | Shared Systems, Inc. | 08/15/1995SE |
| K941398 | EL-RF/3 (Igm-Igg-Iga) KitDHR · Traditional | Theratest Laboratories, Inc. | 07/28/1995SE |
| K942908 | Igm RF EiaDHR · Traditional | Sigma Diagnostics, Inc. | 01/20/1995SE |
| K942328 | N Latex RFDHR · Traditional | Behring Diagnostics, Inc. | 10/20/1994SE |
| K942272 | Igm Rheumatoid FactorDHR · Traditional | Immco Diagnostics, Inc. | 09/26/1994SE |
| K933712 | El-Rf Test System: El-Rf-Igm KitDHR · Traditional | Theratest Laboratories, Inc. | 01/28/1994SE |
| K932437 | Eye Spot RF TestDHR · Traditional | J & S Medical Assoc., Inc. | 08/23/1993SE |
| K926569 | Immuno Ra UndilutedDHR · Traditional | Immunostics Co., Inc. | 04/06/1993SE |
| K915320 | Rheuma-Lex(Tm) Syst: Rheumatoid Factor Latex TestDHR · Traditional | Trinity Laboratories, Inc. | 12/07/1992SE |
| K924036 | Accutex Rheumatiod Factor (RF) Latex TestDHR · Traditional | J.S. Medical Assoc. | 12/01/1992SE |
| K923578 | Liquichek Rheumatoid Factor ControlDHR · Traditional | Bio-Rad | 10/06/1992SE |
| K923771 | Pulse RF TestDHR · Traditional | Pulse Scientific, Inc. | 10/05/1992SE |
| K922725 | Tech Simple Rheumatoid Factor Serum ControlDHR · Traditional | Simplicity Diagnostics, Inc. | 10/05/1992SE |
| K924056 | Encore Rheumatoid Factor EiaDHR · Traditional | Clark Laboratories, Inc. | 09/25/1992SE |
| K922151 | Wako Autokit RFDHR · Traditional | Wako Chemicals USA, Inc. | 07/28/1992SE |
| K920753 | RF Stat Igm Test KitDHR · Traditional | Biowhittaker Molecular Applications, Inc. | 03/30/1992SE |
| K920220 | Healthtest Rheumatoid Factor AssayDHR · Traditional | Akers Research Corp. | 03/13/1992SE |
| K920124 | TurbiquantDHR · Traditional | Behring Diagnostics, Inc. | 03/02/1992SE |
| K904310 | Rheumagen RF T-ControlDHR · Traditional | Biokit USA, Inc. | 05/31/1991SE |
| K910539 | Rheumajet RFDHR · Traditional | Biokit USA, Inc. | 04/05/1991SE |
| K904498 | Cromatest Rheumatoid Diagnostic/Rf Latex TestDHR · Traditional | Biotrax, Inc. | 10/29/1990SE |
| K904105 | V-Trend Target RF TestDHR · Traditional | Texas Immunology, Inc. | 10/15/1990SE |
| K903852 | Rapitex(R) RF NewDHR · Traditional | Behring Diagnostics, Inc. | 08/30/1990SE |
| K902462 | Modified QM300 Rheumatoid Factor TestDHR · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 06/21/1990SE |
| K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)DHR · Traditional | Biokit USA, Inc. | 11/08/1989SE |
| K894574 | Technicon DPA-1 System RF MethodDHR · Traditional | Technicon Instruments Corp. | 08/10/1989SE |
| K892445 | Reaads-Rf Test Kit-SemiquantitativeDHR · Traditional | Biosearch Medical Products, Inc. | 06/05/1989SE |
| K892444 | Reaads-Rf Test Kit-QuantitativeDHR · Traditional | Biosearch Medical Products, Inc. | 06/05/1989SE |
| K884180 | Turbox Rheumatoid Factor Immunological Test SystemDHR · Traditional | Unipath , Ltd. | 02/03/1989SE |
| K883538 | QM300 Calibrator E PackDHR · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/07/1988SE |
| K883536 | QM300 Rheumatoid Factor Antigen PackDHR · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/07/1988SE |
| K883355 | Ubi Magiwel Rf-Igm QuantitativeDHR · Traditional | United Biotech, Inc. | 09/07/1988SE |
| K880164 | RF Card Test & RF Liquid TestDHR · Traditional | Ampcor, Inc. | 02/10/1988SE |
| K874151 | RF Dipstick Test KitDHR · Traditional | Lipogen, Inc. | 12/29/1987SE |
| K873782 | Reuma TestDHR · Traditional | Sclavo, Inc. | 11/27/1987SE |
| K873064 | Amtec Rheumatoid Factor Latex Agglutination KitDHR · Traditional | Amtec Diagnostics International, Inc. | 11/04/1987SE |
| K871196 | Rheuma-Check Enzyme Immunoassay TestDHR · Traditional | Orion Diagnostica, Inc. | 05/06/1987SE |
| K871041 | RF MicroassayDHR · Traditional | Diamedix Corp. | 03/31/1987SE |
| K863238 | Reads RF Test Kit for Igm Rheumatoid FactorDHR · Traditional | Biostar Medical Products, Inc. | 10/08/1986SE |
| K855221 | Seratest RF (Hemagglutination) KitDHR · Traditional | Hemagen Diagnostics, Inc. | 04/22/1986SE |
| K854222 | Diesse RF Test KitDHR · Traditional | Marvic Interpharma, Inc. | 02/06/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | Syn-Kit, Inc. | 01/17/1986SE |
| K853054 | RF Card TestDHR · Traditional | Preco, Inc. | 08/01/1985SE |
| K851537 | Laser RF Control Serum-Quality Control SerumDHR · Traditional | Behring Diagnostics, Inc. | 06/05/1985SE |
| K851099 | Igm Rheumatoid Factor Test KitDHR · Traditional | Breit Laboratories, Inc. | 04/25/1985SE |
| K850296 | Laser RF Test -Rheumatoid Factor(S) ReagentsDHR · Traditional | Behring Diagnostics, Inc. | 04/12/1985SE |
| K850373 | Abbott RF Eia Diagnostic KitDHR · Traditional | Abbott Laboratories | 03/01/1985SE |
| K843896 | Rheumadx Latex Agglutination RheumatoidDHR · Traditional | Diagnostic Products Corp. | 10/25/1984SE |
| K841454 | RF Test KitDHR · Traditional | Difco Laboratories, Inc. | 04/25/1984SE |
| K841146 | NCS Ra Latex TestDHR · Traditional | Ncs Diagnostics, Inc. | 04/20/1984SE |
| K840863 | Seratest RF Latex DeterminationDHR · Traditional | Seragen Diagnostics, Inc. | 04/04/1984SE |
| K840005 | Nabi Rf-Q.S. TestDHR · Traditional | Intl. Diagnostic, Inc. | 02/13/1984SE |
| K840049 | Sopheia MP Igm Rheumatoid Factor EiaDHR · Traditional | Diagnostic Products Corp. | 02/10/1984SE |
| K834391 | Immuno-RaDHR · Traditional | Immunostics Co., Inc. | 02/03/1984SE |
| K831941 | Leap Rheumatoid Factor Test KitDHR · Traditional | Cooper Diagnostics, Inc. | 07/18/1983SE |
| K831597 | Sero/Tex Red Cell RF TestDHR · Traditional | Texas Immunology, Inc. | 06/30/1983SE |
| K831467 | Ra-CheckDHR · Traditional | Diagnostic Technology, Inc. | 06/08/1983SE |
| K830832 | Rheumatoid Factor-Rapid Card Test #65114DHR · Traditional | Emd Chemicals, Inc. | 04/18/1983SE |
| K830611 | Ra Screening TestDHR · Traditional | Tago, Inc. | 03/24/1983SE |
| K822905 | Latest RF Kit for Rheumatoid FactorDHR · Traditional | Fisher Scientific Co., LLC | 10/18/1982SE |
| K821941 | Rheumatoid Factor Reference Prepara.DHR · Traditional | Armkel, LLC | 08/27/1982SE |
| K821319 | Sero/Tex RF TestDHR · Traditional | Texas Immunology, Inc. | 05/21/1982SE |
| K813309 | RA-80 Positive ControlDHR · Traditional | Sun-Kit | 12/17/1981SE |
| K812972 | Ra Latex TestDHR · Traditional | Oxoid U.S.A., Inc. | 11/06/1981SE |
| K812968 | Fiax Rheumatoid Factor Test KitDHR · Traditional | Intl. Diagnostic Technology | 11/06/1981SE |
| K812882 | RheumatexDHR · Traditional | Armkel, LLC | 10/26/1981SE |
| K811375 | Bi-Ra Slide TestDHR · Traditional | Biologics Intl., Inc. | 06/12/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | Calbiochem-Behring Corp. | 03/11/1981SE |
| K810306 | Rheumatoid Factor Reagent Test KitDHR · Traditional | Beckman Instruments, Inc. | 03/11/1981SE |
| K810221 | Scrippsera Theumatoid Factor Refer. CNTLDHR · Traditional | Scripps-Miles, Inc. | 02/09/1981SE |
| K810141 | Scrippsystem Rheumatoid Factor Latex KitDHR · Traditional | Scripps-Miles, Inc. | 02/09/1981SE |
| K802448 | Ra 80 Eiken Kit Determ. of Rheumatic F.DHR · Traditional | Syn-Kit, Inc. | 01/05/1981SE |
| K802688 | Rheumatoid Factor Test SystemsDHR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/18/1980SE |
| K801961 | Rf-Ii Test KitDHR · Traditional | Immuno-Diagnostic Products, Inc. | 10/10/1980SE |
| K800268 | Automated Rhematoid Factor Test (Arft)DHR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/21/1980SE |
| K792697 | Normal Globulin ReagentDHR · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K792695 | Anti-Globulin ControlDHR · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K791507 | Agglutinotest-Rheumatoid ArthritisDHR · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K792061 | Cordia RFDHR · Traditional | Cordis Corp. | 11/27/1979SE |
| K790351 | RheumatellDHR · Traditional | Central Biological Co. | 03/15/1979SE |
| K790012 | Rheumogen Test SystemDHR · Traditional | Calbiochem-Behring Corp. | 01/26/1979SE |
| K771940 | Quantrols RFDHR · Traditional | Organon, Inc. | 11/02/1977SE |
| K771410 | Rheumanosticon RDHR · Traditional | Organon, Inc. | 09/02/1977SE |
| K771552 | Las-R Rheumatoid Factor TestDHR · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 08/30/1977SE |
| K760043 | Test, Rheum. Arth., Card (Macro-Vue)DHR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1976SE |
| K760036 | Test, Latex Slide, Rheumatoid FactorDHR · Traditional | Gamma Biologicals, Inc. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1500-2020 Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product…It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the… | The Binding Site Group, Ltd. | 11/06/2019Terminated |
| Z-2110-2020 Class II | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI:…Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the… | The Binding Site Group, Ltd. | 10/07/2019Terminated |
| Z-0282-2020 Class II | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039…The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British… | Randox Laboratories Ltd. | 08/09/2019Terminated |
| Z-1907-2019 Class II | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the…Potential for reporting low assay results | Phadia Ab | 05/10/2019Terminated |
| Z-2200-2019 Class II | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro…Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a… | Hycor Biomedical Inc | 03/19/2018Open, Classified |
| Z-2134-2019 Class II | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor…Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples… | Hycor Biomedical Inc | 02/21/2018Completed |
| Z-1070-2018 Class II | RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100…All patient serum samples yield a weakly positive test result. | Stanbio Laboratory, LP | 02/13/2018Terminated |
| Z-0553-2018 Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the…The low and high controls for the product are returning results above the assigned values. | The Binding Site Group, Ltd. | 01/04/2018Terminated |
| Z-1546-2012 | RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro…The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a… | Thera Test Laboratories, Inc. | 03/29/2012Terminated |
| Z-0003-2013 Class II | IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE…The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot… | Beckman Coulter Inc. | 01/27/2012Terminated |
| Z-0714-2012 | VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical…Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet… | Ortho-Clinical Diagnostics | 11/10/2011Terminated |
| Z-1194-2012 | SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor…The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid… | Beckman Coulter Inc. | 06/20/2011Terminated |
| Z-2887-2011 | IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot…The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false… | Beckman Coulter Inc. | 05/31/2011Terminated |
| Z-1743-2011 | SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when…The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot… | Beckman Coulter Inc. | 06/21/2010Terminated |