Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Neusoft Medical Systems Co.
Class I - Dangerous
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
PerkinElmer Health Sciences
Class I - Dangerous
A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
Class I - Dangerous
Possibility that a patient or user may be exposed to a very small level of touch current.
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Class I - Dangerous
Unique Device Identifier (UDI) is missing from outer kit box label.
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
Class I - Dangerous
Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.
The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal.
Class I - Dangerous
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.
Class I - Dangerous
The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.
Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
Centurion Medical Products
Class I - Dangerous
The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Ivoclar Vivadent
Class I - Dangerous
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.