RegWardenFDA facility compliance records
Company

Vision Lab Co, LLC

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2016: 1 recalls1’13’141’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIITerminated2016-01-18
    Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
  • Class IIITerminated2015-10-27
    It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.
  • Class IITerminated2013-12-06
    Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

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. “Vision Lab Co, LLC — 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-10093726-vision-lab-co-llc/

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