Class I - Dangerous
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
False positive results due to potential contamination of reagent.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
Class I - Dangerous
One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL.
Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Class I - Dangerous
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Class I - Dangerous
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Class I - Dangerous
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
Thermo Fisher Scientific (Monterrey)
Class I - Dangerous
Product was not irradiated; therefore, they are not sterile and do not meet product specification.