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Beckman Coulter Inc.

526 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A6 recall (Z-0347-2013)Beckman Coulter Inc.2012-11-19
UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clin recall (Z-0123-2013)Beckman Coulter Inc.2012-10-24
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The S recall (Z-0110-2013)Beckman Coulter Inc.2012-10-22
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/250 recall (Z-0056-2013)Beckman Coulter Inc.2012-10-12
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i recall (Z-0059-2013)Beckman Coulter Inc.2012-10-12
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simul recall (Z-0033-2013)Beckman Coulter Inc.2012-10-10
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows si recall (Z-0034-2013)Beckman Coulter Inc.2012-10-10
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enume recall (Z-0035-2013)Beckman Coulter Inc.2012-10-10
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic recall (Z-0046-2013)Beckman Coulter Inc.2012-10-10
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are inte recall (Z-0047-2013)Beckman Coulter Inc.2012-10-10
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 An recall (Z-0021-2013)Beckman Coulter Inc.2012-10-09
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immuno recall (Z-0016-2013)Beckman Coulter Inc.2012-10-05
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microproce recall (Z-0002-2013)Beckman Coulter Inc.2012-10-01
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immuno recall (Z-0003-2013)Beckman Coulter Inc.2012-10-01
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufa recall (Z-2257-2012)Beckman Coulter Inc.2012-08-23
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spo recall (Z-2258-2012)Beckman Coulter Inc.2012-08-23
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i recall (Z-2259-2012)Beckman Coulter Inc.2012-08-23
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is recall (Z-2225-2012)Beckman Coulter Inc.2012-08-20
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer recall (Z-2226-2012)Beckman Coulter Inc.2012-08-20
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative recall (Z-2227-2012)Beckman Coulter Inc.2012-08-20
Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiati recall (Z-1645-2012)Beckman Coulter Inc.2012-05-22
SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with S recall (Z-1432-2012)Beckman Coulter Inc.2012-04-16
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Nu recall (Z-1372-2012)Beckman Coulter Inc.2012-04-06
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part recall (Z-1373-2012)Beckman Coulter Inc.2012-04-06
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 72 recall (Z-1374-2012)Beckman Coulter Inc.2012-04-06
Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i recall (Z-1375-2012)Beckman Coulter Inc.2012-04-06
Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Os recall (Z-1238-2012)Beckman Coulter Inc.2012-03-21
Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring syst recall (Z-1239-2012)Beckman Coulter Inc.2012-03-21
Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase recall (Z-1240-2012)Beckman Coulter Inc.2012-03-21
COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: recall (Z-1241-2012)Beckman Coulter Inc.2012-03-21
COULTER LH 750 Analyzer, part number: LH750 System Help 2D1.103272, PN 6605632, PN 6605632 recall (Z-1242-2012)Beckman Coulter Inc.2012-03-21
COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series Sy recall (Z-1243-2012)Beckman Coulter Inc.2012-03-21
Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman C recall (Z-1229-2012)Beckman Coulter Inc.2012-03-20
ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline ph recall (Z-1195-2012)Beckman Coulter Inc.2012-03-09
SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunolog recall (Z-1194-2012)Beckman Coulter Inc.2012-03-08
Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: K recall (Z-1173-2012)Beckman Coulter Inc.2012-03-06
Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subseq recall (Z-1174-2012)Beckman Coulter Inc.2012-03-06
AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) recall (Z-0974-2012)Beckman Coulter Inc.2012-02-07
AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Cl recall (Z-0975-2012)Beckman Coulter Inc.2012-02-07
AU Clinical Chemistry Analyzers: Model Number: AU2700 Clinical Chemistry Analyzer . The AU recall (Z-0976-2012)Beckman Coulter Inc.2012-02-07
AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU recall (Z-0977-2012)Beckman Coulter Inc.2012-02-07
Access Immunoassay Systems Part Number: 81600 Access 2 Immunoassay Systems Part Number: 81 recall (Z-3126-2011)Beckman Coulter Inc.2012-01-30
UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immun recall (Z-3127-2011)Beckman Coulter Inc.2012-01-30
UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number recall (Z-0452-2012)Beckman Coulter Inc.2012-01-11
Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System I recall (Z-0599-2012)Beckman Coulter Inc.2012-01-11
Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX Hematology An recall (Z-0600-2012)Beckman Coulter Inc.2012-01-11
Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. H recall (Z-0601-2012)Beckman Coulter Inc.2012-01-11
COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number: 670 recall (Z-0602-2012)Beckman Coulter Inc.2012-01-11
SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, recall (Z-0124-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX4 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON CX4 recall (Z-0125-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4 DEL recall (Z-0126-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX5 Clinical System Part #: 759300 Product Usage: The Beckman SYNCHRON CX4 DELTA, recall (Z-0127-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX5 Delta Clinical System Part #: 468243 Product Usage: The Beckman SYNCHRON CX4 recall (Z-0128-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4 DEL recall (Z-0129-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4 DELTA, recall (Z-0130-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX7 Delta Clinical System Part #: 468205 Product Usage: The Beckman SYNCHRON CX4 recall (Z-0131-2012)Beckman Coulter Inc.2011-10-27
SYNCHRON CX9 Delta ALX System Part #: 473513 Product Usage: The Beckman SYNCHRON CX4 DELTA recall (Z-0132-2012)Beckman Coulter Inc.2011-10-27
Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particl recall (Z-0050-2012)Beckman Coulter Inc.2011-10-17
Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018 recall (Z-0028-2012)Beckman Coulter Inc.2011-10-07
COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse i recall (Z-3263-2011)Beckman Coulter Inc.2011-09-19
Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is int recall (Z-3128-2011)Beckman Coulter Inc.2011-09-02
Unicel DxH 800 Coulter Cellular Analysis System Product Usage: UniCel DxH 800 Coulter Cell recall (Z-3125-2011)Beckman Coulter Inc.2011-09-01
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Co recall (Z-3027-2011)Beckman Coulter Inc.2011-08-16
Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estri recall (Z-3023-2011)Beckman Coulter Inc.2011-08-15
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Nu recall (Z-2887-2011)Beckman Coulter Inc.2011-07-27
DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determinat recall (Z-2882-2011)Beckman Coulter Inc.2011-07-26
UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integr recall (Z-2771-2011)Beckman Coulter Inc.2011-07-11
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The Inhib recall (Z-2772-2011)Beckman Coulter Inc.2011-07-11
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhi recall (Z-2773-2011)Beckman Coulter Inc.2011-07-11
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The Inhib recall (Z-2774-2011)Beckman Coulter Inc.2011-07-11
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4 The Inhi recall (Z-2775-2011)Beckman Coulter Inc.2011-07-11
Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoas recall (Z-2761-2011)Beckman Coulter Inc.2011-07-08
Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software v recall (Z-2685-2011)Beckman Coulter Inc.2011-06-28
Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software v recall (Z-2686-2011)Beckman Coulter Inc.2011-06-28
Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembl recall (Z-2633-2011)Beckman Coulter Inc.2011-06-23
Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibr recall (Z-2605-2011)Beckman Coulter Inc.2011-06-21
Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC i recall (Z-2606-2011)Beckman Coulter Inc.2011-06-21
SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Cou recall (Z-2226-2011)Beckman Coulter Inc.2011-05-20
Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology anal recall (Z-2227-2011)Beckman Coulter Inc.2011-05-20
COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instruction recall (Z-2231-2011)Beckman Coulter Inc.2011-05-20
AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate The AutoMate sy recall (Z-2212-2011)Beckman Coulter Inc.2011-05-19
COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent recall (Z-2213-2011)Beckman Coulter Inc.2011-05-19
Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to ai recall (Z-2215-2011)Beckman Coulter Inc.2011-05-19
IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, recall (Z-2184-2011)Beckman Coulter Inc.2011-05-11
Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177 recall (Z-2170-2011)Beckman Coulter Inc.2011-05-10
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 An recall (Z-2172-2011)Beckman Coulter Inc.2011-05-10
Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic. recall (Z-2178-2011)Beckman Coulter Inc.2011-05-10
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 An recall (Z-2157-2011)Beckman Coulter Inc.2011-05-09
Synchron LX20, Part Number: 466200. Designed for the in vitro determination of a variety o recall (Z-2130-2011)Beckman Coulter Inc.2011-05-06
Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a varie recall (Z-2131-2011)Beckman Coulter Inc.2011-05-06
Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variet recall (Z-2132-2011)Beckman Coulter Inc.2011-05-06
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800 A recall (Z-2145-2011)Beckman Coulter Inc.2011-05-05
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 An recall (Z-2148-2011)Beckman Coulter Inc.2011-05-05
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-2128-2011)Beckman Coulter Inc.2011-05-02
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-2114-2011)Beckman Coulter Inc.2011-04-29
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Ana recall (Z-2121-2011)Beckman Coulter Inc.2011-04-29
Synchron LX I 725 The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer and recall (Z-2070-2011)Beckman Coulter Inc.2011-04-26
Synchron LX 20 PRO The SYNCHRON LX20 PRO is a fully automated, computer-controlled clinica recall (Z-2071-2011)Beckman Coulter Inc.2011-04-26
Synchron LX 20 The Synchron LX Systems are fully automated, computer-controlled clinical c recall (Z-2072-2011)Beckman Coulter Inc.2011-04-26
UniCel DxC860i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel D recall (Z-2073-2011)Beckman Coulter Inc.2011-04-26
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