BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed component lots were contained in product 519700 component case. This occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. This issue was immediately contained and corrected. A full inventory analysis was conducted reviewing all vacutainer component inventories. The issue was found to affect a total of five vacutainer components.
The stopcock was found to have punctures.
Class I - Dangerous
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
ORTHO-CLINICAL DIAGNOSTICS
Class I - Dangerous
Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
Unapproved change made by the supplier.
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
Nihon Kohden America
Class I - Dangerous
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
Ge Medical Systems Information T
Class I - Dangerous
It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
Class I - Dangerous
The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.
High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
Class I - Dangerous
Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.