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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 3 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	39V1001	FDA UDI	Class I	Active
Leica Biosystems	000000000038440208	FDA UDI	Class I	Active
Leica Biosystems Ariol Rare Event Module	23ASWRE	FDA UDI	Class II	Active
Leica Biosystems	39LC-605-3-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM6000 B CytoVision Basic Configuration	23MIC1200	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Microscope, Leica DM6000B for Capture	23MIC6003	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision K/F Station w/ Jai MV4 Camera	23CAP001KFX001	FDA UDI	Class II	Unknown
Leica Biosystems	3800459CL	FDA UDI	Class I	Active
Leica Biosystems	39LC-700-3	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM5500 B ERGO Head Version	23MIC1208	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038440600	FDA UDI	Class I	Active
Leica Biosystems Ariol Large Stage 8 slides	23AC8BAYV1	FDA UDI	Class II	Active
Leica Biosystems	38440001	FDA UDI	Class I	Active
Leica Biosystems	38440304	FDA UDI	Class I	Active
Leica Biosystems	000000000003801320	FDA UDI	Class I	Active
Leica Biosystems	000000000003801615	FDA UDI	Class I	Active
Leica Biosystems	38440103	FDA UDI	Class I	Active
Leica Biosystems	38440002	FDA UDI	Class I	Active
Leica Biosystems	3800373	FDA UDI	Class I	Active
Leica Biosystems	38441407	FDA UDI	Class I	Active
Leica Biosystems	39LC-610-10-L	FDA UDI	Class I	Active
Leica Biosystems	3800455	FDA UDI	Class I	Active
Leica Biosystems	3800146G	FDA UDI	Class I	Active
Leica Biosystems CytoVision CV FIlter Wheel and Controller, 10x32mm	23MICFWLFXX002	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-705-1	FDA UDI	Class I	Active
Leica Biosystems	39LC-605-6-L	FDA UDI	Class I	Active
Leica Biosystems Ariol Small Stage 4 Slides	23AC4BAYV1	FDA UDI	Class II	Active
Leica Biosystems	39LC-610-11-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-4-L	FDA UDI	Class I	Active
Leica Biosystems	3800458CL	FDA UDI	Class I	Active
Leica Biosystems	39LC-610-3-L	FDA UDI	Class I	Active
Leica Biosystems	3800074	FDA UDI	Class I	Active
Leica Biosystems	000000000003800350	FDA UDI	Class I	Active
Leica Biosystems	000000000038441302	FDA UDI	Class I	Active
Leica Biosystems CytoVision FISH Station w/ Jai MV4 Camera	23CAP001FXX001	FDA UDI	Class II	Unknown
Leica Biosystems DELL 7910 CV Ultimate Service PC	23CPU7910ULT_SPARE	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-10-L	FDA UDI	Class I	Active
Leica Biosystems	38440006	FDA UDI	Class I	Active
Leica Biosystems	000000000038441604	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-7-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision Spot Counting Software	23SWRSPOTXX001	FDA UDI	Class II	Unknown
Leica Biosystems	38440107	FDA UDI	Class I	Active
Leica Biosystems	38440010	FDA UDI	Class I	Active
Leica Biosystems	3802741	FDA UDI	Class I	Active
Leica Biosystems	000000000003800383	FDA UDI	Class I	Active
Leica Biosystems	3803015	FDA UDI	Class I	Active
Leica CytoVision Karyotyping review software (inc. dongle)	23SWR000KXX001	FDA UDI	Class II	Unknown
Leica Biosystems	3800205AE	FDA UDI	Class I	Active
Leica Biosystems	3800456CL	FDA UDI	Class I	Active
Leica Biosystems	3800145ACS	FDA UDI	Class I	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.