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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 11 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems CytoVision Station Upgrade use existing Jai A10	23CUP006CVXA10	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441304	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL FL 63X	23OBJ063PLFDRY	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-610-6-L	FDA UDI	Class I	Active
Leica Biosystems	38441121	FDA UDI	Class I	Active
Leica Biosystems GSL POWER SUPPLY KIT	23GSLPSA1	FDA UDI	Class II	Unknown
Leica Biosystems	3803081	FDA UDI	Class I	Active
Leica Biosystems	3801085	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL120 scanning system for Karyotyping	23GSL120KXX001	FDA UDI	Class II	Active
Leica Biosystems CytoVision DM5500B for Brightfield & FL	23MIC550KFX002	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-11-L	FDA UDI	Class I	Active
Leica Biosystems	38440404	FDA UDI	Class I	Active
Leica Biosystems	3800115ACS	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-2-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Ultimate	23DKI5810	FDA UDI	Class II	Unknown
Leica Biosystems	3800040	FDA UDI	Class I	Active
Leica Biosystems Ariol UPS 110V	23UPS2207	FDA UDI	Class II	Active
Leica Biosystems CytoVision Dell Ultrasharp U2415 Monitor	23MON0024	FDA UDI	Class II	Unknown
Leica Biosystems GSL120-Base Assembly BX	23GSL0012	FDA UDI	Class II	Unknown
Leica Biosystems	3803065	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-10-L	FDA UDI	Class I	Active
Leica Biosystems Ariol 200 Slide loader	23ASL200L	FDA UDI	Class II	Active
Leica Biosystems	000000000038441400	FDA UDI	Class I	Active
Leica Biosystems	39LC-610-7-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision FISH review software (inc. dongle)	23SWR000FXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Manual Brightfield Capt Sys	23CAP009KXX001	FDA UDI	Class II	Unknown
Leica Biosystems	3800085E	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-10-L	FDA UDI	Class I	Active
Leica Biosystems	3800075	FDA UDI	Class I	Active
Leica Biosystems	000000000038440206	FDA UDI	Class I	Active
Leica Biosystems	000000000003803805	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-11-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-6-500	FDA UDI	Class I	Active
Leica Biosystems	3803075	FDA UDI	Class I	Active
Leica Biosystems	000000000038441401	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version	23GSLXXXKFXUPG	FDA UDI	Class II	Unknown
Leica Biosystems	39V3001	EUDAMEDFDA UDI	Class I	Active
Leica Biosystems	38440507	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-2-500	FDA UDI	Class I	Active
Leica Biosystems	000000000003800363	FDA UDI	Class I	Active
Leica Biosystems	3801060	FDA UDI	Class I	Active
Leica Biosystems CytoVision	23NWKTSVXXX002	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038440200	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-5-L	FDA UDI	Class I	Active
Leica Biosystems	38441122	FDA UDI	Class I	Active
Leica Biosystems	3800380	FDA UDI	Class I	Active
Leica Biosystems	39LC-610-8-L	FDA UDI	Class I	Active
Leica Biosystems	38441406	FDA UDI	Class I	Active
Leica Biosystems	000000000038440205	FDA UDI	Class I	Active
Leica Ariol SL200 Basw Workstation	23ASLDMWS	FDA UDI	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.