Facility

Vitrolife Inc.

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

Key facts

1recalls · worst Class II

3inspections · 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)	3002757762
Establishment type	Manufacture Medical Device
Location	4940 Carroll Canyon Rd Ste 100 San Diego, CA, US 92121
Registration status	Active · expires 2026
Parent company	VITROLIFE AB (owner-operator 9037178)
Brand names	MicroCell

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Hemocytometer
Product code GHO (opens in a new tab) · Class I · Hematology · 21 CFR 864.6160

Recalls & enforcement

Class IITerminated2014-12-22
The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.

FDA inspections (3)

VAI2025-01-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2021-08-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-09-21
No 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.

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. “Vitrolife Inc. (FEI 3002757762) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002757762-vitrolife-inc/

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