23andMe, Inc. Personal Genome Service®(PGS) YouDotRecalls & reported problems
23andme Genomics LLC · 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859462006262), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Emotional Changes1
- Laceration(s)1
- Scar Tissue1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2022Use of Device Problem; Use of Device Problem
DESCRIPTION OF EVENT PULLED FROM ON ANONYMOUS MEDWATCH REPORT - REPORT #MW5110108. INVOLUNTARY PSYCHIATRIC HOLD; MY (B)(6) NIECE WAS PROVIDED A 23-AND-ME TEST KIT DIRECTLY BY HER SCHOOL WITHOUT OBTAINING PARENTAL CONSENT FOR THE MEDICAL PROCEDURE. IT INCLUDED THE FDA-LICENSED DIRECTTO-CONSUMER "BRCA BREAST CANCER GENES" TEST, APPROVED FOR MARKETING IN MARCH 2018. THE COMPANY, 23- AND-ME PROVIDED MY NIECE A LAB RESULT DIRECTLY STATING THAT SHE WAS A MUTANT, WOULD GET CANCER, AND DIE. THIS CAUSED HER PROFOUND PSYCHOLOGICAL HARM, ALL WITHOUT KNOWLEDGE OF THE FAMILY. SHE STARTED HATING HER BODY AND STARTED TAKING A RAZOR BLADE TO HER BREASTS, CAUSING SCARS. SHE LATER BECAME SO PARALYZED BY FEAR AT SCHOOL THAT THE NURSE CALLED THE POLICE AND SHE WAS ADMITTED INVOLUNTARILY INTO A (B)(6) INPATIENT PSYCHIATRIC FACILITY AND GIVEN VERY DANGEROUS AND TOXIC PSYCHIATRIC MEDS AGAINST HER FAMILY'S WILL. THIS CAUSED HER TO LOSE MORE THAN A MONTH OF SCHOOL, AND SHE'S GIVEN UP ON HOMEWORK, SAYING "WELL, I'M GOING TO DIE ANYWAY." SHE THEN STARTED FALSELY CLAIMING IN THE PSYCH WARD SHE WAS TRANSGENDERED AS A WAY TO GET APPROVED FOR A RADICAL DOUBLE MASTECTOMY, AND WE ARE HAVING A PROBLEM WITH CHILD PR
Patient problems: Emotional Changes; Laceration(s); Scar Tissue
MAUDE report 14890894 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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