RegWardenFDA facility compliance records
Facility

Vitrolife Inc.

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2019: 2 inspections1’14’15’16’17’182’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

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 (2)

  • NAI2019-12-09
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2019-02-13
    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.

Related

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 3003274090) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003274090-vitrolife-inc/

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