Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

Dynex Agility Sample Tips;

The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.

Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.

Hydroflex ELISA

The batteries have the potential to overheating, melt or char.

VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user inter

The keyboard and monitor may not be properly secured to the monitor arm.

PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC.

The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.

MagNA Pure LC 1.0 (software version 3.0.11).

Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.

MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)

Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.

AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate

The recall was initiated because Beckman Coulter has confirmed an issue with the AutoMate Sample Processing Systems. If during the recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the AutoMate.

Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic

Protruding screw threads may cut the user when cleaning the interior of the instrument.