Instrument, Coagulation, Automated
FDA adverse event reports and recall history for instrument, coagulation, automated (product code GKP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 661
- Deaths
- 13
- Injuries
- 70
- Malfunctions
- 531
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-09-12Open, ClassifiedUnder Investigation by firm
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 assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
- 2022-04-28Open, ClassifiedUnder Investigation by firm
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
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
- 2014-07-16TerminatedDevice Design
ACL TOP (Base), automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2014-07-16TerminatedDevice Design
ACL TOP 700, automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2014-07-16TerminatedDevice Design
ACL TOP CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2014-07-16TerminatedDevice Design
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2014-07-16TerminatedDevice Design
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2014-07-16TerminatedDevice Design
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2014-07-16TerminatedDevice Design
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Potential for sample misidentification.
- 2013-09-18TerminatedDevice Design
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Monitor instrument, coagulation, automated automatically
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