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Leica Biosystems Richmond, Inc.

United States·US-MF-000014614

Last updated September 17, 2026

Information

Country: United States
Address: 5205, US Route 12, Richmond, United States
Website: leicabiosystems.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Heloiza Chirnev
EUDAMED SRN: US-MF-000014614
FDA FEI Number: 1419341
DUNS Number: —

Catalogue (583)

Page 12 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	38440005	FDA UDI	Class I	Active
Leica Biosystems	39LC-605-1-L	FDA UDI	Class I	Active
Leica Biosystems Slide Cassettes, SL200	23ASLSP003	FDA UDI	Class II	Active
Leica Biosystems	39LC-675-5-500	FDA UDI	Class I	Active
Leica Biosystems	3800082E	FDA UDI	Class I	Active
Leica Biosystems CytoVision Microscope, Leica DM5500B	23MIC5500	FDA UDI	Class II	Unknown
Leica Biosystems	3801092	FDA UDI	Class I	Active
Leica Biosystems Ariol SL200 Stage	23ASLSTAGE	FDA UDI	Class II	Active
Leica Biosystems	38440400	FDA UDI	Class I	Active
Leica Biosystems	3808103GEP	FDA UDI	Class I	Active
Leica Biosystems	3800444CL	FDA UDI	Class I	Active
Leica Biosystems CytoVision Station Upgrade use existing Jai CVM2	23CUP005CVMV2	FDA UDI	Class II	Unknown
Leica Biosystems Ariol TMA Module	23ASWTMA	FDA UDI	Class II	Active
Leica Biosystems CytoVision Brightfield & FL ChromaScan upgrade	23MBX008KFXUPG	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Removable Archive Device	23STR003XXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Microscope, Leica DM2500	23MIC2500	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision V7.4 configuration	23SWR000CVX740	FDA UDI	Class II	Unknown
Leica Biosystems Ariol Leica DM6000B Ariol	23MIC6005	FDA UDI	Class II	Active
Leica Biosystems HIGH TRANSM. AQUA FOR LEICA DM	232FLAL312372	FDA UDI	Class II	Unknown
Leica Biosystems Ariol PL220 Automatic Oiler	23ASLSP031	FDA UDI	Class II	Active
Leica Biosystems HIGH TRANSM. RED FOR LEICA DM	232FLAL324872	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Citrix Server (incl. 1x CV)	23NWKCSVXXXCV1	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Capture Station Upgrade with Jai CVM2	23CUP002CVX720	FDA UDI	Class II	Unknown
Leica Biosystems RDX QUICKSTOR 8863 USB3	23RDX8863	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Microscope, Leica DM5000B	23MIC5000	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision FISH Software Upgrade	23SWR001FLX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Tissue FISH Software	23SWRTFHXXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision OBJ HC PL APO 63X OIL	23OBJ063PAPOIL01	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Station License transfer to SW Review	23REVTSFXXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision CV TERMINAL SERVER USER LICENSE K/F	23SWRRMTKFX016	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision OBJ HC PL FL 10X	23OBJ010PLFDRY	FDA UDI	Class II	Unknown
X-tra Clipped Corner Adhesive Slides, Green	3800203E	FDA UDI	Class I	Active
Leica Fl800	K141136	FDA 510(k)	Class II	Active

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 14, 2017	Z-3125-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3124-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3122-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3120-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3123-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3121-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3126-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
May 6, 2016	Z-1948-2016	—	terminated	An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.
May 2, 2016	Z-2039-2016	—	terminated	Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
Feb 20, 2012	Z-1331-2012	—	terminated	Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product.