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Ortho Cinical Diagnostics (quidelortho) has determined that some lots from coating 3598 of Vitros Eco2 Slides include carts which may contain consecutive slides that may not function as intended. These affected Vitros Eco2 slides (potentially…

Nova Biomedical became aware of a potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new bun/creatinine sensor cartridge. The potential risk is within the first 2-4 hours after cartridge…

When turning on biofire torch Systems, arcing inside of the power switch may result in carbon build‐up on the switch contacts. The carbon build‐up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power…

Internal testing identified that the Gem Paks (cartridges) for the Gem Premier 3x00 with IGM, Gem Premier 4000 with IGM, and Gem Premier 5000 with IGM2 of impacted cartridge lots may experience an increase in CVP (Gem Premier 4000 Paks and Gem Premier…

After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. this monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems…

Sentinel Ch Spa, the manufacturer of iron for use with Architect and Alinity C Iron Reagent Kit, has identified an issue with the reagents. Some customers have experienced elevated quality control (QC) results as well as elevated patient results. A high…

Siemens Healthcare Diagnostics Inc. has determined that two drugs, perhexiline maleate and atomoxetine hydrochloride, may interfere with sodium results that are reported on the RAPIDPoint® 500 and RAPIDPoint® 500e Blood Gas Systems.  Recall start…

Ortho Clinical Diagnostics (Quidelortho) determined that lots 5905-3348-1557 and 5905-3348-2899 of Vitros Lipase Slides include carts which may contain consecutive slides that may not function as intended. Quidelortho estimates that approximately 1.4% of…

On 05/05/2023 customer in lab in Switzerland identified that two Multichem® S Plus vials were cracked at the bottom and material was leaking from the vial. No actual end-user/patient harm was identified as a result of the cracked vial. Recall start…

It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures. Recall start date…

Certain proboscis/piston assembly (or assemblies) manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause Vitros® Versatips and/…

Affected lots can include plates, which are slightly higher than normally, and the plates may rest higher on the instrument adapter (plates manufactured by our supplier using a different mold). This may result in run failure due to issues with moving the…

Randox laboratories can confirm that there has been a transcription error in the instructions for use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3, LAE4215, lot 1308UE. For caeruloplasmin, the one and two standard deviation values…

Internal testing determined that IgA OSR61171 failed to meet the interference claim as stated per the IFU for the lipemic serum interference. All lots of IgA OSR61171 are affected. Recall start date: July 17, 2023

In April 2023 Beckman Coulter distributed a letter that provided alternate access thyroglobulin calibrator cards for use with the thyg reagent packs.It has been determined through an internal investigation that when used the calibrator card will cause a…