Hardy Diagnostics—HardyCHROM MRSA Media: May Yield False-Positive Results

​ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

FDA's Center for Devices and Radiological Health (CDRH) states that use of the above media may generate false-positive results. FDA's CDRH also states that the manufacturer initiated a recall by Notification of Recall letter on November 14, 2019. The manufacturer has not confirmed the...