Instrument, Coagulation, Automated
Hematology · 21 CFR 864.5400
Recent MDR events
661 adverse event reports on file
- BCS XP SYSTEMJun 29, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00020
- ACL TOP 750 LASNov 22, 2024InjuryInstrumentation Laboratory Co.1217183-2024-00008
- ASSY, SYSTEM, ACL TOP 750 LASNov 21, 2024InjuryInstrumentation Laboratory Co.1217183-2024-00007
- ACL TOP 750 LASNov 15, 2024MalfunctionInstrumentation Laboratory Company20693891
- ACL TOP 550 CTSNov 6, 2024InjuryInstrumentation Laboratory Co.1217183-2024-00006
- BCS XP SYSTEMAug 22, 2024MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2024-00025
- ACL TOP 500 CTSOct 13, 2023InjuryInstrumentation Laboratory Co.1217183-2023-00004
- ACL TOP 750 CTSMay 19, 2023MalfunctionInstrumentation Laboratory Co.1217183-2023-00002
- ACL TOP 500 CTSMay 17, 2023InjuryInstrumentation Laboratory Co.1217183-2023-00001
- BCS XP SYSTEMFeb 10, 2023MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2023-00004
Event type breakdown
Recalls
31 recall events for this product code
- Instrumentation LaboratoryOpen, ClassifiedSep 12, 2023
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the as
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Z-2578-2023 · View FDA record ↗ - Instrumentation LaboratoryOpen, ClassifiedApr 28, 2022
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
Z-1014-2022 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP (Base), automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2060-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP 700, automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2061-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2062-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2063-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2064-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2065-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedJul 16, 2014
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
Z-2066-2014 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedSep 18, 2013
ACL TOP (Base); PN 0000280000
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Z-2244-2013 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Sysmex Corporation I-square
Kakogawa Hyogo, JP
Instrumentation Laboratory Co.
Bedford, MA, US
Diamond Diagnostics Inc.
Budapest, HU
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Sysmex Corporation
KOBE Hyogo, JP
Sysmex Corporation Techno Park
KOBE Hyogo, JP
Fisher Diagnostics
MIDDLETOWN, VA, US
Sysmex America, Inc. - Vernon Hills
Vernon Hills, IL, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Diagnostica Stago - Gennevilliers
Gennevilliers Hauts-de-Seine, FR
Helena Laboratories, Corp.
BEAUMONT, TX, US
Sysmex Corporation Kakogawa Factory
Kakogawa Hyogo, JP
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Bemotec Gmbh
Sonnenbühl Baden-Wurttemberg, DE
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Sysmex America, Inc.
Lincolnshire, IL, US
510(k) clearances
49 clearances for this product code
- Instrumentation Laboratory (IL) Co.Aug 16, 2024
K242127 · ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
- Instrumentation Laboratory CompanyJun 21, 2023
K231031 · ACL TOP Family 70 Series
- Instrumentation Laboratory COMar 3, 2016
K160276 · ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- Instrumentation Laboratory CODec 13, 2015
K150877 · ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- Instrumentation Laboratory COSep 22, 2009
K091980 · ACL TOP 700 LAS
- Instrumentation Laboratory COMay 4, 2008
K073377 · ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
- Instrumentation Laboratory COJan 12, 2007
K063679 · ACL TOP
- Instrumentation Laboratory COJan 12, 2004
K033414 · ACL TOP MODEL, TOP