SEKISUI Diagnostics, LLC

• PSZ — Microbiology3 devices
• GNX — Microbiology1 device
• KHE — Hematology1 device
• KTN — Immunology1 device

• Z-0015-2014 — Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.Class II·Terminated·2013-09-16
• Z-0463-2013 — Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.Class II·Terminated·2012-10-24
• Z-2431-2012 — Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.Class II·Terminated·2012-08-28
• Z-1902-2012 — MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.Class II·Terminated·2012-05-29

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K241188 — Acucy® Influenza A&B Test with the Acucy® 2 SystemCode PSZ·2025-04-18
• K192719 — Osom Ultra Plus Flu A&B Test KitCode PSZ·2020-04-03
• K182001 — Acucy Influenza A&B Test with the Acucy SystemCode PSZ·2018-12-17
• K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestCode KTN·2018-06-22
• K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITCode KHE·2012-12-28
• K123182 — OSOM INFLUENZA A&B TEST MODEL 190Code GNX·2012-11-05