Activated Partial Thromboplastin
Hematology · 21 CFR 864.7925
Recent MDR events
96 adverse event reports on file
- HEMOSIL SYNTHASILJul 10, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00015
- HEMOSIL SYNTHASILJun 23, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00012
- HEMOSIL SYNTHASILJun 10, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00011
- HEMOSIL SYNTHASILJun 3, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00010
- HEMOSIL SYNTHASILMay 19, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00008
- PATHROMTIN SLMay 15, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00011
- HEMOSIL SYNTHASILMay 4, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00005
- HEMOSIL SYNTHASILApr 14, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00003
- HEMOSIL SYNTHASILApr 1, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00002
- HEMOSIL SYNTHASILFeb 10, 2026MalfunctionInstrumentation Laboratory Co.1217183-2026-00001
Event type breakdown
Recalls
10 recall events for this product code
- Instrumentation LaboratoryOpen, ClassifiedJan 15, 2026
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of
Potential for microbial contamination.
Z-1095-2026 · View FDA record ↗ - Instrumentation LaboratoryOpen, ClassifiedDec 17, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
Z-0938-2026 · View FDA record ↗ - Helena Laboratories, Corp.TerminatedSep 27, 2019
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Z-2761-2019 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedJun 2, 2015
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thrombopla
Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.
Z-1703-2015 · View FDA record ↗ - ITC-Nexus DxTerminatedFeb 6, 2014
Hemochron Jr. Citrate APTT Cuvette
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Z-0937-2014 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedAug 26, 2006
Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
Z-1441-06 · View FDA record ↗ - Dade Behring , Inc.TerminatedJul 20, 2004
Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
cloudy appearance or precipitate
Z-0773-04 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedUnknown
Staclot LA (REF 00600)
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Z-0610-2019 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedUnknown
Staclot LA 20 (REF 00594)
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Z-0611-2019 · View FDA record ↗ - Helena Laboratories, Corp.TerminatedUnknown
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial T
Intermittent potential for shorter than expected clot times.
Z-1108-2021 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Biomedica Diagnostics Inc.
Windsor Nova Scotia, CA
Instrumentation Laboratory Co.
Bedford, MA, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Fisher Diagnostics
MIDDLETOWN, VA, US
High Technology, Inc.
North Attleboro, MA, US
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Tcoag Ireland Limited
BRAY Wicklow, IE
Helena Laboratories, Corp.
BEAUMONT, TX, US
Sanzay Corporation -
Miami Gardens, FL, US
Accriva Diagnostics, Inc.
San Diego, CA, US
Teco Diagnostics
ANAHEIM, CA, US
Precision Biologic Inc.
Dartmouth Nova Scotia, CA
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
510(k) clearances
52 clearances for this product code
- Instrumentation Laboratory (IL) Co.Jan 9, 2026
K253957 · HemosIL Silica Clotting Time
- Precision BiologicOct 23, 2020
K193556 · Cryocheck Hex LA
- Instrumentation Laboratory COMar 16, 2016
K160445 · HemosIL Silica Clotting Time
- Diagnostica Stago, Inc.May 4, 2006
K053111 · STA-CEPHASCREEN KIT
- Instrumentation Laboratory COApr 13, 2006
K060688 · HEMOSIL SYNTHASIL
- Instrumentation Laboratory COMar 30, 2005
K050221 · HEMOSIL SILICA CLOTTING TIME
- Vital Scientific N.V.Nov 1, 2002
K022021 · VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
- Careside Hemotology, Inc.Feb 8, 2002
K014028 · CARESIDE APTT