When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Class I - Dangerous
ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Class I - Dangerous
FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Mindray DS USA, Inc.
Class I - Dangerous
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
Class I - Dangerous
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Class I - Dangerous
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Class I - Dangerous
There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.
Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
Omega Medical Imaging
Class I - Dangerous
Elevating Monitor Suspension column dropping and will not rise back up.
Potential for early component failure.