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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 7 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	38441123	FDA UDI	Class I	Active
Smart-UPS SMC1500i 1500VA 230V	23UPS2216	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision OBJ HC PL FL 5X	23OBJ005PLFDRY	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-500-6-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision FISH Software License Activation Code	23SWR000FLX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision KT & FISH Capture Station with Jai CVM2	23CAP003KFX001	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-675-11-500	FDA UDI	Class I	Active
Leica Biosystems	39LC-610-5-L	FDA UDI	Class I	Active
Leica Biosystems	3800084CL	FDA UDI	Class I	Active
Leica Biosystems	3803084	FDA UDI	Class I	Active
Leica Biosystems	000000000038440204	FDA UDI	Class I	Active
Leica Biosystems	000000000003802916	FDA UDI	Class I	Active
Leica Biosystems	39LC-605-8-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-8-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-4-L	FDA UDI	Class I	Active
Leica Biosystems	3800083E	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM5500 B CytoVision Basic Configuration	23MIC1205	FDA UDI	Class II	Unknown
Leica Biosystems SURGE SUPPRESSOR ISOBAR6ULTRAHG-120V	23PSU0016	FDA UDI	Class II	Unknown
Leica Biosystems Ariol Review Station	23ADMR	FDA UDI	Class II	Active
Leica Biosystems Ariol Y and Z Axis Drive Belts (2 Belts), SL200	23ASLSP018	FDA UDI	Class II	Active
Leica Biosystems	000000000003800209	FDA UDI	Class I	Active
Leica Biosystems	3800060CL	FDA UDI	Class I	Active
Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished	23MIC1201R	FDA UDI	Class II	Active
Leica Biosystems	3808101GEP	FDA UDI	Class I	Active
Leica Biosystem	000000000003803595	FDA UDI	Class I	Active
Leica Biosystems CytoVision V7.5 configuration	23SWR00075CV	FDA UDI	Class II	Unknown
Leica Biosystems Lamp Housing 107, 12V 100W, 1 Lens	23MIC4080	FDA UDI	Class II	Unknown
ThermoBrite	3800-004852-004	FDA UDI	Class I	Active
Leica Biosystems	3800302	FDA UDI	Class I	Active
Leica Biosystems	3800375	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PC FL 100X Oil	23OBJ100PLFOIL	FDA UDI	Class II	Unknown
Leica Biosystems	3802743	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-6-L	FDA UDI	Class I	Active
Leica Biosystems	000000000038441309	FDA UDI	Class I	Active
Leica Biosystems	3800081E	FDA UDI	Class I	Active
Leica Biosystems CytoVision HD with Image, Dell T7500 RAID 1, Win 7	23DKI7517	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Karyotyping & FISH Review software	23SWR000KFX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision KVM/Monitor	23SVR009XXX001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441510	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-9-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-10-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-4-L	FDA UDI	Class I	Active
Leica Biosystems	38441601	FDA UDI	Class I	Active
Leica Biosystems	000000000038441402	FDA UDI	Class I	Active
Win10 Cpu Upgrade For Gsl(in Warranty)	23GSLWARW10CPU	FDA UDI	Class II	Unknown
Leica Biosystems	3801656	FDA UDI	Class I	Active
Leica Biosystems	3800443CL	FDA UDI	Class I	Active
Leica Biosystems	3800086CL	FDA UDI	Class I	Active
Leica Biosystems	3800079	FDA UDI	Class I	Active
Leica Biosystems	3800202E	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.