AlereTM 92225Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10815845020116), received between Jan 14, 2019 and Dec 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 reports).

1 FDA recall record name this device's identifier, 1 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.

Recalls naming this device

1. 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-3272-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 2 FALSE POSITIVE HCG RESULTS WHILE TESTING ALERE HCG (SERUM/URINE) DEVICES ON TWO DIFFERENT PATIENTS. THE SECOND PATIENT PRESENTED ON (B)(6) 2024 PRIOR TO UNDERGOING AN UNSPECIFIED SURGICAL PROCEDURE. THE PATIENT PROVIDED A FRESH URINE SAMPLE WAS PROVIDED, WHICH WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. A FAINT POSITIVE RESULT WAS REPORTED. AS A RESULT OF THE POSITIVE RESULT, RETESTING WAS PERFORMED USING A DIFFERENT DEVICE FROM THE SAME KIT AND A NEGATIVE HCG RESULT WAS OBTAINED. THE CUSTOMER REPORTED NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE FALSE POSITIVE RESULT. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2024-00217 FOR THE MDR FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20958916 ↗
• MalfunctionDec 17, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 2 FALSE POSITIVE HCG RESULTS WHILE TESTING ALERE HCG (SERUM/URINE) DEVICES ON TWO DIFFERENT PATIENTS. THE FIRST PATIENT PRESENTED ON (B)(6) 2024 PRIOR TO UNDERGOING AN UNSPECIFIED SURGICAL PROCEDURE. THE PATIENT PROVIDED A FRESH URINE SAMPLE WAS PROVIDED, WHICH WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. A FAINT POSITIVE RESULT WAS REPORTED. AS A RESULT OF THE POSITIVE RESULT, RETESTING WAS PERFORMED USING A DIFFERENT DEVICE FROM THE SAME KIT AND A NEGATIVE HCG RESULT WAS OBTAINED. THE CUSTOMER REPORTED NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE FALSE POSITIVE RESULT. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2024-00218 FOR THE MDR FOR THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20958595 ↗
• MalfunctionJul 16, 2021False Positive Result; False Positive Result

  UNSPECIFIED DATE: FALSE POSITIVE RESULT OBTAINED ON THE HCG ONE STEP PREGNANCY TEST DEVICE. LINE WAS A WEAK POSITIVE, SO THE SAMPLE WAS SENT TO THE LAB FOR A CONFIRMATORY HCG QUANT. CONFIRMATORY QUANT PROVIDED A NEGATIVE RESULT; EXACT RESULT NOT PROVIDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. CUSTOMER UNRESPONSIVE.

  Patient problems: Insufficient Information

  MAUDE report 12180436 ↗
• MalfunctionJan 14, 2019False Negative Result; False Negative Result

  (B)(6) 2018: PATIENT PRESENTED FOR A COLPOSCOPY MID-MORNING. A NEGATIVE RESULT WAS OBTAINED ON THE ALERE HCG COMBO CASSETTE. THE COLPOSCOPY WAS PERFORMED BASED ON THE FALSE NEGATIVE RESULT. SOMETIME BETWEEN 30-60 MINUTES LATER, THE MEDICAL ASSISTANT NOTICED A TEST LINE. THE URINE SAMPLE WAS REPEATED 2X AND A POSITIVE RESULT WAS OBTAINED BOTH TIMES. BLOOD WORK WAS PERFORMED THE SAME DAY AND THE RESULT WAS POSITIVE AT 3310 MIU/ML. ALTHOUGH THE COLPOSCOPY WAS PERFORMED BASED ON THE FALSE NEGATIVE HCG RESULT, THE PHYSICIAN STATES THE PROCEDURE WOULD HAVE BEEN PERFORMED REGARDLESS OF WHETHER THE RESULT WAS POSITIVE. CUSTOMER STATES THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8244800 ↗