Facility

CELLAVISION AB

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003630693
Establishment type	Complaint File Establishment per 21 CFR 820.198; Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	Mobilvagen 12 LUND Skane, SE 22362
Registration status	Active · expires 2026
Parent company	CellaVision AB (owner-operator 9043433)
Brand names	CellaVision DM96 and DM1200 with Advanced RBC Application; CellaVision DM9600 with Advanced RBC Application; DI-60 with Advanced RBC Application

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Device, Automated Cell-Locating
Product code JOY (opens in a new tab) · Class II · Hematology · 21 CFR 864.5260

Recalls & enforcement

Class IIOngoing2025-10-08
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Class IIOngoing2017-12-04
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

FDA inspections (1)

NAI2016-11-16
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by CellaVision AB

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CELLAVISION AB (FEI 3003630693) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003630693-cellavision-ab/

Not open yet

Alerts for CELLAVISION AB

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.