ENDOMAGNETICS LTD

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibratio…

Due to product exhibiting potential to generate either invalid or false negative results.

Presence of particulates in affected devices that can be deposited into breast tissue during use.

Fungal contamination of affected lot with Parengyodontium album.

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN…

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility b…

Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acc…

Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the…

Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.

Use of assay along with plasma specimen may result in error code which would invalidate sample.

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on t…

Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

Failed stability specifications for reagent kits that may result in false negative test results.

There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.

Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.

The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to i…

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.

An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

The firm is implementing a product correction involving its Affirm® Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-appro…

A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.

Breach in sterile barrier compromising product sterility

Incorrect label on the Sertera Biopsy Kit

Tip Breakage at the glue joint between the obturator body and tip

Cracks ATEC Canister Lids.

Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,

Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180® around vertical axis as well as 180® around a horizontal axis…