AlereTM 92211Recalls & reported problems
Alere San Diego, Inc. · Alere™ hCG Dipstick (25mIU/mL) in Urine · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815845020093), received between Mar 5, 2026 and Mar 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 20, 2026Open, Classified
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Z-3273-2026 · Root cause: Device Design · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1606-2022 · Root cause: Environmental control · FDA record ↗
Most reported problems
Device problems
- False Positive Result1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT WITH THE ALERE HCG DIPSTICK. THE PATIENT DENIED BEING SEXUALLY ACTIVE. THE TEST WAS REPEATED, HOWEVER THE RESULT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520766 ↗MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED "INDETERMINATE" RESULT WHEN TESTING A PATIENT WITH THE ALERE HCG DIPSTICK. THE PATIENT WAS TESTED, THEN PROVIDED A SECOND URINE SAMPLE, WHICH WAS ALSO TESTED. THE SPECIFIC RESULTS OBTAINED WERE NOT PROVIDED. IT IS CONSERVATIVELY ASSUMED THAT AT LEAST ONE RESULT WAS BELIEVED TO BE FALSE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520708 ↗
Other Visual, Pregnancy Hcg, Prescription Use devices
- McKesson 5001Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls165 reports
- CARDINAL HEALTH B1077-23Cardinal Health 200, LLC · Visual, pregnancy hCG, prescription use1 recall149 reports
- McKesson 5000Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls90 reports
- McKesson 5002Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls33 reports
- Sure-Vue 4581405021Fisher Scientific Company L.L.C. · Visual, pregnancy hCG, prescription use1 recall83 reports
- Henry Schein 9004072Henry Schein, Inc. · Visual, pregnancy hCG, prescription use1 recall79 reports
- AlereTM 92210Alere San Diego, Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls23 reports
- MEDLINE MPH12025HCGMedline Industries, Inc. · Visual, pregnancy hCG, prescription use1 recall69 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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