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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 6 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems CytoVision Karyotype & FISH Software Update	23SWR002KFL001	FDA UDI	Class II	Unknown
Leica Biosystems	38440008	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-4-500	FDA UDI	Class I	Active
Leica Biosystems	38440607	FDA UDI	Class I	Active
Leica Biosystems Ariol Camera Large, Jai CVM2	23ACM2	FDA UDI	Class II	Active
Leica Biosystems	39LC-605-10-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL FL 1.25X	23OBJ125PLFDRY	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-5-L	FDA UDI	Class I	Active
Leica Biosystems	000000000003802098	FDA UDI	Class I	Active
Leica Biosystems	3800448CL	FDA UDI	Class I	Active
Leica Biosystems	000000000003800310	FDA UDI	Class I	Active
Leica Biosystems	000000000038440207	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-10-500	FDA UDI	Class I	Active
Leica Biosystems	3802641T	FDA UDI	Class I	Active
Leica Biosystems	3800201AE	FDA UDI	Class I	Active
Leica Biosystems	39LC-550-6-L	FDA UDI	Class I	Active
Leica Biosystems	3801659	FDA UDI	Class I	Active
Leica Biosystems Ariol Automatic Oiler	23ASLOILER	FDA UDI	Class II	Active
Leica Biosystems CytoVision FISH Review Station	23REV000FXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision HP 24" Wide-Screen Monitor	23MON0023	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-4-L	FDA UDI	Class I	Active
Leica Biosystems Nvidia Quadro 600	23BDG0031	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Remote User (Karyotype)	23SWRRMTKXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Karyotyping Station without Camera	23CAP001KXX201	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Review Station Upgrade	23REV001XXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM6000B for Brightfield & FL	23MIC600KFX002	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441503	FDA UDI	Class I	Active
Leica Biosystems	3800447CL	FDA UDI	Class I	Active
Leica Biosystems	000000000003800207	FDA UDI	Class I	Active
Leica Biosystems	3800449	FDA UDI	Class I	Active
Leica Biosystems Ariol Power Distribution 110V	23SCR110V	FDA UDI	Class II	Unknown
Leica Biosystems	3800455CL	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-5-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-9-L	FDA UDI	Class I	Active
Leica Biosystems Ariol Fluorescent Module	23ASWFL	FDA UDI	Class II	Active
Leica Biosystems	000000000003801540	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-2-L	FDA UDI	Class I	Active
Leica Biosystems	000000000003801619	FDA UDI	Class I	Active
Leica Biosystems	S21.2113.A	FDA UDI	Class I	Active
Leica Biosystems	38440007	FDA UDI	Class I	Active
Leica Biosystems Barcode 2D Scanner & Stand	23SCN1903	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003800016	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM6000 B ERGO Head Version	23MIC1209	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003800388	FDA UDI	Class I	Active
Leica Biosystems	3800086E	FDA UDI	Class I	Active
Leica Biosystems	3800121G	FDA UDI	Class I	Active
Leica Biosystems	000000000038441607	FDA UDI	Class I	Active
Leica Biosystems	000000000038441608	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM6000B for Brightfield Cap	23MIC600KXX002	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Karyotyping & FISH SW for Citrix	23SWR000KFX002	FDA UDI	Class II	Unknown

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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.