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GE Healthcare has become aware of two potential issues where inaccurate distance and area measurements can be displayed. Recall start date: May 5, 2022

A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a…

The STO2 values may be inaccurately low when using either the fore-sight elite tissue oximeter module (Model HEMFSM10) or the fore-sight elite absolute tissue oximeter monitor (Model 01-06-3000) with the fore-sight elite large sensor (…

Baxter Corporation is issuing a correction for the Prismax. If the operator initiates therapy by entering a value other than the default value for the patient gain/loss limit or the return pressure drop limit and uses the same patient function, the…

Siemens Healthcare Diagnostics Inc. has confirmed the potential for falsely elevated hcg results due to sample carryover. This can be observed when a sample is assayed for HCG immediately after an undiluted sample with a HCG value of GT;5000 MIU/mL. This…

Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate…

FA-000604, which was distributed in August 2021, notified customers of possible intra-assay carryover. The letter communicated that clinically significant carryover into a reagent pack (into-pack) can occur if an Access Hstni test is performed after a…

We have become aware of a potential carryover issue that 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…

Positive, instead of negative, results have been reported by customers for the low control and patient samples for Quantum Blue® Anti-Infliximab production Series 1107. The increased false-positive rate was confirmed internally at Bühlmann. Approximately…

In April 2021, while finalizing the review of complaint case-2020-00909902 related to a Minimed 630g insulin pump user who was hospitalized with hyperglycemia and DKA (diabetic ketoacidosis) on 07-dec-2020, Medtronic medical safety personnel noticed that…

In July 2021, two dedicated impact assessments were discussed during a triage meeting for the service pack release of software version 5.0.1. the first assessment related to the potential for the robotic arm to move into the work volume…

When the specific circumstances described below occur, there is a possibility of displaying distorted images along with erroneous measurements. the distortion and measurement difference could affect decisions regarding patient care.…

System overestimates the circumference when the manual trace function is used. the trace circumference value is overestimated; however, the area value is accurate. the issue is present in Sequoia's VA20A/VA25 onward as the VA20A introduced a…

If prior to the IFR/FFR pullback on the intrasight system, FFR measurement(s) were performed within the same syncvision procedural session, the co-registered distal value will be different than the distal value displayed in the philips IFR/FFR system.…

Cardinal Health has initiated a medical device correction for specific production lots of non-absorbent towels due to varying levels of adhesion. Cardinal Health is conducting this correction due to the potential for the non-absorbent towels to have…