Company: Biomeme, Inc. Date of Enforcement Report: 2/10/2021 Class III PRODUCT Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler...Read More

Company: Topcon Medical Systems, Inc. Date of Enforcement Report: 2/10/2021 Class II PRODUCT Harmony Referral System (aka Harmony RS)/ Medical Device Data System – Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information. Recall Number: Z-0952-2021 REASON Harmony RS integrations with Topcon equipment,...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report: 2/10/2021 Class II PRODUCT Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx...Read More

Company: Community Blood Center of the Ozarks Date of Enforcement Report: 2/10/2021 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0216-2021 REASON Blood products, associated with a blood bank software glitch, were distributed. RECALLING FIRM/MANUFACTURER Community Blood Center of the Ozarks on 9/25/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More