AlereTM 92215Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10815845020123), received between Jul 25, 2018 and Jun 21, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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-3271-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING ALERE HCG STRIP URINE TESTS FOR TWO PATIENTS. THE SECOND PATIENT PRESENTED ON (B)(6) 2024 FOR HCG TESTING PRIOR TO AN IUD PLACEMENT FOR CONTRACEPTION. THE PATIENT PROVIDED A FRESH URINE SAMPLE. THREE DROPS OF URINE WERE APPLIED TO THE DEVICE AND THE RESULTS WERE READ AT 3 MINUTES 30 SECONDS YIELDING A POSITIVE HCG RESULT. THE CUSTOMER REPORTED AN ADDITIONAL TEST WAS PERFORMED WHICH ALSO YIELDED A POSITIVE HCG RESULT, HOWEVER IT IS UNCLEAR WHICH DEVICE YIELDED THIS ADDITIONAL FALSE HCG RESULT. CONFIRMATORY BLOOD HCG TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589564 ↗
• MalfunctionJun 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING ALERE HCG STRIP URINE TESTS FOR TWO PATIENTS. THE FIRST PATIENT PRESENTED ON (B)(6) 2024 FOR HCG TESTING, PRIOR TO NEXPLANON PLACEMENT FOR CONTRACEPTION. THE PATIENT PROVIDED A FRESH URINE SAMPLE. THREE DROPS OF URINE WERE APPLIED TO THE DEVICE AND THE RESULTS WERE READ AT 4 MINUTES YIELDING A POSITIVE HCG RESULT. CONFIRMATORY BLOOD HCG TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585753 ↗
• MalfunctionSep 13, 2022False Positive Result; False Positive Result

  UNSPECIFIED DATE: CUSTOMER REPORTED SEVERAL FALSE POSITIVE RESULTS WHEN TESTING WITH THE ALERE HCG COMBO CASSETTE. NO ADVERSE OUTCOMES REPORTED. THE EXACT FREQUENCY OR NUMBER OF PATIENTS INVOLVED WAS NOT PROVIDED. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED AT INTAKE.

  Patient problems: Insufficient Information

  MAUDE report 15414645 ↗
• MalfunctionMay 17, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT 2 FALSE POSITIVE RESULTS OCCURRED WHEN USING A URINE SAMPLE ON THE ALERE HCG COMBO TEST DEVICE (SERUM/URINE) PRIOR TO AN ELECTIVE COLONOSCOPY PROCEDURE. CONFIRMATORY TESTS WITH A BLOOD SAMPLE WERE PERFORMED WITH AN UNKNOWN METHOD, BHCG QUANT ON (B)(6) 2022 WAS A NEGATIVE RESULT, 0.2MIU/ML. THE PROCEDURE WAS TO BE RESCHEDULED. NO ADVERSE EVENS OCCURRED DUE TO THE DELAY IN THE COLONOSCOPY PROCEDURE. MEDICATIONS: ADDERALL XR 15 MG EXTENDED RELEASE CAPSULE TAKE 15 MG BY MOUTH EVERY MORNING. DULCOLAX 5 MG ENTERIC COATED TABLET PLEASE TAKE AS DIRECTED AT BEDTIME 2 DAYS PRIOR TO GI PROCEDURE. CATAPRES 0.1 MG TABLET TAKE 1/2 TO 1 TABLET BY MOUTH AT BEDTIME AS NEEDED FOR SLEEP. FLEXERIL 10 MG TABLET TAKE 1 TABLET BY MOUTH 2 TIMES A DAY AS NEEDED FOR MUSCLE SPASMS FOR UP TO 7 DAYS. PRISTIQ 100 MG EXTENDED RELEASE TABLET TAKE BY MOUTH DAILY. AVAPRO 300 MG TABLET. LISINOPRIL 5 MG TABLET TAKE 5 MG BY MOUTH DAILY WITH FOOD. MULTIVITAMIN TABLET TAKE 1 TABLET BY MOUTH DAILY. PRILOSEC 40 MG DELAYED RELEASE CAPSULE TAKE 40 MG BY MOUTH DAILY WITH FOOD. GOLYTELY SOLUTION PLEASE TAKE HALF OF PREP SOLUTION AT 9 PM NIGHT BEFORE GI PROCEDURE, AND SECOND HALF OF PREP 6 HOURS PRIO

  Patient problems: Insufficient Information

  MAUDE report 14419587 ↗
• MalfunctionMay 17, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 4 FALSE POSITIVE RESULTS WHEN USING A URINE SAMPLE ON THE ALERE HCG TEST DEVICE (SERUM/URINE) PRIOR TO AN ELECTIVE COLONOSCOPY PROCEDURE. CONFIRMATORY BLOOD TESTS WERE PERFORMED WITH AN UNKNOWN METHOD WITH NEGATIVE RESULTS, BHCG QUANT ON (B)(6) 2022 WAS <0.2. THE PROCEDURE WAS PERFORMED THE FOLLOWING DAY. NO ADVERSE EVENTS OCCURRED DUE THE DELAY IN THE COLONOSCOPY PROCEDURE. MEDICATIONS: DULCOLAX 5 MG EC 2 DAYS BEFORE PROCEDURE. BLISOVI 24 FE 1-20 MG-MCG PO QD. GOLYTELY 1/2 SOL. 9PM NIGHT BEFORE PROCEDURE. GOLYTELY 1/2 SOL. 6 HOURS BEFORE PROCEDURE. ZOLOFT 50 MG TAB 100 MG PO QD. ZOLOFT 100 MG TAB 100 MG PO QD. MULTIVITAMIN 1 TAB PO QD WITH FOOD. MULTIPLE VITAMINS/WOMENS PO 1 QD.

  Patient problems: Insufficient Information

  MAUDE report 14419320 ↗
• MalfunctionJul 25, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, THE PATIENT WAS TESTED FOR PREGNANCY PRIOR TO AN UNSPECIFIED PROCEDURE. A SERUM SAMPLE WAS COLLECTED AND PRODUCED A NEGATIVE HCG RESULT USING AN ALERE HCG COMBO CASSETTE AT A READ TIME OF FIVE TO SIX MINUTES. HOWEVER, THE CUSTOMER REPORTED OBSERVING A FAINT POSITIVE LINE APPEAR APPROXIMATELY ONE MINUTE LATER. PER THE CUSTOMER, A TIMER WAS NOT USED FOR THE TEST. THE CUSTOMER EXPECTED A NEGATIVE RESULT BECAUSE THE PATIENT WAS POST-MENOPAUSAL. THE ALERE HCG COMBO CASSETTE TEST WAS REPEATED THREE ADDITIONAL TIMES AND A FAINT LINE CONTINUED TO APPEAR APPROXIMATELY ONE MINUTE AFTER THE READ. A SERUM QUANTITATIVE TEST WAS PERFORMED AND PRODUCED A POSITIVE HCG RESULT OF ">5." THE CUSTOMER WAS UNABLE TO FURTHER CLARIFY THE QUANTITATIVE RESULT BUT STATED THE HCG RESULT INDICATED THE PATIENT WAS POSITIVE FOR PREGNANCY. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION REGARDING WHETHER THE UNSPECIFIED PROCEDURE WAS PERFORMED BUT NO ADVERSE PATIENT OUTCOME REPORTED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED OF THE REQUIREMENT OF A TIMER TO ENSURE THE RESULT IS INTERPRETED AT THE DESIGNATED READ TIME. FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE LEVELS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719341 ↗