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Abbott I Stat Cartridge Recall
abbott i stat cartridge recall















If you need priority delivery on this item, please remove the item from the cart and call 80 to speak with a sales representative who can assist in having this item expedited from the manufacturer.Used in nearly 10,000 healthcare facilities around the world, the i-STAT System features a. Please note this item may ship standard ground delivery service. Cable LAN Filter For i-STAT Ea 1249638 Abbott Point Of Care 06F23-63.

abbott i stat cartridge recall

Test management issues should be resolved by taking the view that it is a ‘point-of-care’ test, and by looking at the specific test technology and method involved, rather than by just assuming it is a ‘haematology’ or a ‘chemistry’ test.Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. These views must be considered when designing an overall PoCT management plan. 51 + 536.64 51 + 536.64Specialties other than clinical chemistry may have differing views on traditional test management, particularly with regard to quality control (QC), quality assurance (QA), and training. It performs a battery of tests and is designed for the i-STAT 1 Handheld Analyzer system. It is intended to be a resource for any pathologist who The CHEM 8+ i-STAT cartridge is a single-use in vitro diagnostic test contained in a pocket sized cartridge.

To avoid confusion, any advice given to clinical staff regarding their analysers should be clear, concise, and above all else, consistent.Abbott Point Of Care Inc. Clinical users of a combined PoCT system are principally interested in the generation of good quality results. I-STAT 1 ANALYZER SYSTEM - PT/INR CARTRIDGE AND. I-STAT PT/INR CARTRIDGES Manufacturer ABBOTT LABORATORIES LIMITED.

1 , 2Point-of-care haematology testing can be performed with dedicated PoCT analysers. These tests are usually regarded as ‘haematology’ tests and are commonly used in the management of infection, haemorrhage, and oral and intravenous anticoagulants. In some institutions, this continues to be the case.Whilst this attachment has continued to serve PoCT well into the 21 st century, an increasing number of testing devices are being marketed which perform tests such as the white cell count (WCC), haematocrit (Hct) and haemoglobin (Hb), prothrombin time/international normalised ratio (PT/INR), activated clotting time (ACT), and the activated partial thromboplastin time (APTT). This paradigm has probably arisen because historically a majority of point-of-care tests such as blood gas analysis and blood glucose testing have indeed been derived directly from clinical chemistry.

Only 33 of the analyser locations have on-site laboratories the remainder are non-laboratory sites such as small rural hospitals and primary health care clinics. This network is considered the largest in the world and provides basic testing capabilities over a considerable geographical area. These tests include arterial and venous blood gas and electrolytes, common metabolites, cardiac troponin I (TnI), Hct and Hb, and coagulation tests such as the INR and ACT.Here I describe the selection, management and use of the i-STAT analyser as a combined chemistry/haematology analyser in an integrated testing network consisting of 195 analysers, covering approximately 140 sites across the state of Queensland.

Most of their immediate needs can be supplied by a few ‘basic’ chemistry and haematology tests. They do not have intensive care or complex surgical units to support. Often a simpler solution was to fly the patient to a larger facility for testing and treatment.The on-site testing requirements for these small district hospitals are not extensive. Long specimen transport distances, intermittent transport availability and high summer temperatures continually challenged the ability of established laboratories to provide reliable results in an acceptable time frame for management of the acutely ill patient. 3Running a Combined Chemistry/Haematology Point-of-Care Service – Why We Use the i-STATThe Pathology Queensland Point of Care Testing network originated in 2001 with the aim of providing on-site access to basic pathology tests for the many small rural and remote hospitals in Queensland.

4Many of these remote facilities conduct oral anticoagulant outpatient clinics or hospital in the home programs, where the availability of PoCT can reduce or eliminate the need to recall a patient for treatment changes. It can also mean a safer and better managed stay for less acute inpatients. 5The immediate availability of these tests can literally mean the difference between keeping and treating an emergency patient on the one hand and an emergency medivac flight on the other. The only important test missing is the WCC differential which can be supplied by other point-of-care instruments.

Haemoglobin concentration is calculated from the Hct using a standard equation.Due to the wide range of tests performed by the analyser, a variety of QC materials are required although the processes are simplified as far as possible.QC of the blood gas/chemistry cartridges is performed using routine liquid bi- or tri-level aqueous control material familiar to operators of conventional blood gas analysers.A frozen plasma-based material is used for TnI and BNP QC.Coagulation tests utilise a lyophilised citrated whole plasma material which is re-calcified immediately prior to use. There are some limitations to this method as significant deviations from an assumed plasma protein concentration may affect results. INR is ‘calibrated’ using the same ‘International Sensitivity Index’ system as is used for laboratory thromboplastin reagents.Measurement of Hct is based on plasma conductivity the electrical resistance of a whole blood sample is proportional to its Hct. This is achieved through thrombin cleaving an electrochemical substrate rather than fibrinogen. To switch from one test group to another, one simply changes to a different cartridge type.Blood gases, electrolytes, creatinine and urea are performed using a miniaturised version of traditional electrode technology contained within the test cartridge.TnI and brain natriuretic peptide (BNP) tests use a sandwich-type immunoassay with electrochemical rather than optical detection.PT/INR uses a recombinant human thromboplastin with electrochemical detection of the ‘clotting’ endpoint. The test sample and reagents never enter the ‘analyser’ which transforms electrical signals from the test cartridge into human-readable results.The individual tests are arranged in traditional blood gas or chemistry groupings on a single use cartridge.

Drawing from our data outlined above, we note:Use of disposable test cartridges which the user does not need to ‘calibrate’ in the field.As the sample makes contact only with the cartridge, the analyser does not get ‘dirty’ or require regular maintenance beyond a simple electronic QC check each day of use and a wipe clean as required. Elements of good laboratory practice such as QC, QA and training programs are naturally retained but they require modification to suit the purposes of remote PoCT and non-laboratory users.The process begins with careful study of the i-STAT instrument and its testing methodologies, combined with input from multiple pathology disciplines. Further QC should be in line with local practice and regulation.Tailoring a Management Program for the i-STAT – Combining Chemistry and Haematology PoCTThe best approach is to look at the PoCT system as a new way to provide a pathology testing service, and to construct a dedicated management framework accordingly. This type of material is also seldom used in clinical chemistry.The manufacturer’s recommendation for cartridge QC is to test multiple levels on each lot number at delivery.

The difference here is that the group administers an entire state rather than a single hospital. The organisation is modelled after specialist PoCT consulting groups as used and peer recommended in the USA and UK/Europe. The chair and deputy chair are a multi-skilled pathologist and scientist respectively. The group has a varied membership comprising representatives from clinical chemistry, haematology, microbiology and quality management as well as scientific and clinical end users from all levels of the chain.

The regional laboratories manage the local purchase, QC and distribution of test cartridges as well as the installation of new analysers and training of operators as required.

abbott i stat cartridge recall