RegWardenFDA facility compliance records
Company

VITROLIFE AB

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

Recalls by year

FDA actions on record by year2014: 1 recalls1’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)

Registered facilities (3)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “VITROLIFE AB — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9037178-vitrolife-ab/

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