Potential for leaking product
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Potential for leaking product
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
Potential for leaking product
Potential for leaking product
Potential for leaking product
Potential for leaking product
Potential for leaking product
Potential for leaking product
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Class I - Dangerous
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Abbott Laboratories
Class I - Dangerous
The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
B. Braun Medical
Class I - Dangerous
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Class I - Dangerous
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Becton Dickinson &
Class I - Dangerous
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Becton Dickinson &
Class I - Dangerous
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Ad-Tech Medical Instrument
Class I - Dangerous
Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Leventon S. A. U.
Class I - Dangerous
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.