Facility

Menarini Silicon Biosystems Inc.

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

Key facts

2recalls · worst Class II

1inspections · worst VAI

—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)	3004153557
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	3401 Masons Mill road Huntingdon Valley, PA, US 19006
Registration status	Active · expires 2026
Parent company	Menarini Silicon Biosystems Inc. (owner-operator 10054393)
Brand names	CellSearch AutoPrep Samples Prep system

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Apparatus, Automated Blood Cell Diluting
Product code GKH (opens in a new tab) · Class I · Hematology · 21 CFR 864.5240

Recalls & enforcement

Class IIOngoing2022-05-20
High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
Class IITerminated2018-04-04
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

FDA inspections (1)

VAI2017-10-04
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 Menarini Silicon Biosystems Inc.

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. “Menarini Silicon Biosystems Inc. (FEI 3004153557) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004153557-menarini-silicon-biosystems-inc/

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