Analyzer, Heparin, Automated

Reports per year

Source: FDA adverse event reports by year received, 2004–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2010-03-11TerminatedOther

  Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.

  Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o

• 2004-07-20TerminatedOther

  STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.

  Incorrect assay ranges on the assay value insert for Heparin Control 5.