Recalls and Safety Alerts:
Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall
The centrifuge’s bucket and insert may not be seated on the rotor, breaking the lid and being forced out of the centrifuge...
Mobile Medical Applications
FDA has defined a small subset of mobile medical apps that may impact the performance or functionality of currently regulated medical devices and will require FDA oversight...
Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
This update informs the public that serious complications associated with surgical mesh for transvaginal repair of POP are not rare, a change from what the FDA previously reported in 2008...
GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall
Potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer...
Highlighted Articles:
Laboratory Medicine Best Practices: Systematic Evidence Review and Evaluation Methods for Quality Improvement
With these methods, evidence from quality improvement studies can be systematically synthesized and summarized to identify effective laboratory medicine practices...
Safety Tip: Develop Specific Work Practices for Individual Experiments
LSI believes that the scope of particularly hazardous substances should be expanded...
Alarming Monitor Problems
Follow-up investigations often showed that users weren't familiar with how the monitoring equipment worked or hadn't checked the monitor's alarm status...
Patient-Assisted Incident Reporting: Including the Patient in Patient Safety
The authors present a case which illustrates the use of eliciting the patient's perspective to provide a complementary perspective to the provider's description of the event...
Pediatric Medical Devices
Designing pediatric medical devices can be challenging and also bring up new concerns about device longevity and long-term exposure to implanted materials...
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
