|
Association of Indian Medical Device Industry (AIMED)
Abstracts Of Regulatory Report – July 2011
FDA WARNING LETTERS
HEALTH CANADA NEWS
GENERAL ANNOUNCEMENTS
The following topics are among those being presented during
the Medical Device Information Session: four recently-updated guidance documents
(including Recalls of Medical Devices, Mandatory Problem Reporting, User Problem
Reporting, and Investigation of Reported Medical Device Problems); signal
detection and assessment and recent changes to Establishing Licensing.
During the months of September and October, 2011, Health
Canada will be delivering these one-day information sessions in the following
seven Canadian cities: St. John's, Halifax, Montreal, Toronto, Winnipeg,
Calgary, and Vancouver.
For a schedule please visit
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md-im_session_ltr-eng.php
RECENT ADVISORIES, WARNINGS AND RECALLS
AGFA Healthcare NV – Impax for Cardiology, Clinical Review
Station
When using the Impax CV reporting (RM) module, PDF renderings
of final reports may be inaccessible if a merge was performed on a previously
signed report.
AGFA Healthcare NV - Impax Cardiovascular (CV) Admin Tool
If the end-user requests to move a report into a study that
currently has a report associated with it, the system will allow the move,
however the result is that there is no indication that the moved report exists
when viewing the study through the user interface.
AGFA Healthcare NV - Impax for Cardiology
AGFA initially identified the need for CRS upgrades when a
customer in Canada, Edmonton Cardiology Consultants, performed echocardiography
volume measurements within CRS that were not reflected correctly in associated
results management (RM) reports. connexes.
B&B Medical Technologies – StabilTube, E.T. Tape, E.T.
Tape II
B&B Medical has been advised by the supplier of the skin prep
pad, Smith & Nephew, that due to manufacturing problems they are recalling their
skin prep products. The pads are provided in each package of B&B Medical E.T.
Tape.
Beckman Coulter, Inc. - PK7300 Automated Microplate System
- Instrument Class 3, Beckman Coulter PK7300 Automated Microplate System (Donor
Screening) – Instrument
The content of the PK7300 on-line help file and the PK7300
user's guide are different. Change control is in place for hard copy versions of
the user's guide and the local hard copy is the primary reference for the
operators. There is no assurance that the on-line version of the user's guide
has up to date "instructions for use" in all languages.
Beckman Coulter, Inc. – Leukosure Enumeration Kit
There is incorrect activity levels stated on the instructions
for use labeling in the Leukosure Enumeration Kit due to the inaccurate activity
values provided by the supplier for the raw material ribo-nuclease a type III-A,
utilized as a component of the Leukosure
Stain Reagent. The activity value for these lots is
3.25ku/ml, as compared to 4ku/ml as stated in the product labeling. Alteration
of the staining enumeration of white blood cells (WBC) in blood component
preparation might produce falsely high values of white blood cells in samples
with high levels of residual RNA. These high values may result in the the blood
component being considered inappropriate for use in transfusions, thereby
reducing the availability of blood for transfusion procedures. The high values
may also result in unnecessary reprocessing of the blood component.
Beckman Coulter, Inc. - Access Testosterone Reagent Pack
and Calibrator
Beckman Coulter Inc. identified the following issue with the
above listed products: 1. The dilution recovery (linearity) data presented in
the Access Testosterone instructions for use (IFU) does not represent the
current product performance. 2. In a recent study, thirty-four (34) male serum
samples with testosterone values from 4 to 10ng/ml were diluted 1/2 in Access
Testosterone Calibrator S0. The neat and diluted samples were then measured
using the Access Testosterone Assay. The calculated mean recover was 110% (range
= 95 to 137%).
Becton, Dickinson and Company - BD FACS 7-Color Setup
Beads
Sensitivity failures on BD FACS 7 Color Setup Beads, causing
failure on the BD Facscanto or Facscanto II Systems BD FACS 7 Colour Setup
report.
Davol, Inc., Subsidiary of C.R. Bard Inc. - Avitene
Microfibrillar Collagen, Web; EndoAvitene Microfibrillar Collagen; Syrine
Avitene Microfibrillar Collagen; Avitene UltraFoam; Avitene Microfibrillar
Collagen Flour
The Avitene instructions for use (IFU) have been revised to
include a warning or precaution on the possible development of post-operative
inflammatory reaction to the device, including its clinical features and its
timing.
|
