Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
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
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
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
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
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.