COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Class I - Dangerous
DualStop Caps defect causing leaks in affected product
Class I - Dangerous
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.
Class I - Dangerous
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Azurion FlexArm, 722079
Philips North America
Class I - Dangerous
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Arrow International
Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Class I - Dangerous
Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Arrow International
Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Class I - Dangerous
Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Becton Dickinson & Company
Class I - Dangerous
The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Advanced Bionics
Class I - Dangerous
The sound processors were loaded with the incorrect firmware.