AlereTM 92217Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10815845020109), received between Jul 11, 2018 and Jul 20, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 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-3274-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021False Positive Result; False Positive Result

  (B)(6) 2021: PATIENT PRESENTED TO THE FACILITY COMPLAINING OF NAUSEA AND VOMITING. PER CLINIC WORKFLOW, MA WILL COLLECT URINE FOR URINE DIPSTICK AND URINE HCG ON FEMALES THAT ARE OF CHILD BEARING AGE. A PATIENT URINE SPECIMEN WAS TESTED ON THE HCG ONE STEP PREGNANCY TEST DEVICE KIT AND A FALSE POSITIVE RESULT WAS OBTAINED. TWO OTHER TESTS FROM THE SAME BOX HAD PROVIDED A NEGATIVE RESULT FOR THE PATIENT AND A THIRD TEST WAS USED FROM A SECOND BOX, WHICH ALSO PROVIDED A NEGATIVE RESULT. THE SAME SAMPLE WAS USED FOR ALL FOUR TESTS. A CONFIRMATORY BLOOD HCG WAS PERFORMED WHICH PROVIDED A NEGATIVE RESULT. EXACT RESULT AND METHODOLOGY NOT PROVIDED. PATIENT WAS INSTRUCTED TO STAY WELL HYDRATED TO AVOID DEHYDRATION. THE CUSTOMER REPORTED THAT BASED ON EVALUATION, NO OTHER TREATMENT WAS REQUIRED; SUPPORTIVE CARE ONLY. LATER THAT DAY, AN OUTSIDE PROVIDER DIAGNOSED THE PATIENT WITH A RUPTURED OVARIAN CYST. THE PATIENT IS PRESENTLY STABLE. THIS DEVICE IS NOT INTENDED TO DIAGNOSE WHETHER A PATIENT HAS AN OVARIAN CYST. THE CLINICIAN'S CARE IS BASED ON A FULL EVALUATION AND NOT AS A RESULT OF THE HCG TEST. THE RUPTURING OF THE CYST IS NOT RELATED TO THE FALSE POSITIVE HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200408 ↗
• MalfunctionApr 16, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE URINE RESULT AFTER PERFORMING AN HCG TEST WITH A PATIENT ON (B)(6) 2020. THE PATIENT ALLEGEDLY PERFORMED 8 PREGNANCY TESTS AT HOME WHICH WERE POSITIVE. A SERUM SAMPLE WAS DRAWN AND THE RESULT WAS 224 IU/ML. A CLINICIAN RETESTED THE URINE SPECIMEN AND OBSERVED THAT THE TEST RESULT WAS POSITIVE. THE CONTROLS PERFORMED AS EXPECTED, TECHNIQUE AND PROCEDURE WERE FOLLOWED. SUBSEQUENTLY, THE CARE COORDINATOR OF THE MEDICAL CENTER RAN THE SAME URINE SAMPLE ON 10 HCG TESTS WITH POSITIVE RESULTS. THERE WAS NO TREATMENT, PROCEDURE OR MEDICATION CHANGED FOR THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968358 ↗
• InjuryOct 16, 2019False Negative Result; False Negative Result

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING ABDOMINAL PAIN AND A RAPID HCG TEST WAS ADMINISTERED WHICH PRODUCED A FALSE NEGATIVE RESULT. THE PATIENT WAS THEN SENT FOR A CAT SCAN TO DETERMINE THE ETIOLOGY OF THE ABDOMINAL PAIN. THE RESULT WAS SUSPECTED PREGNANCY. THE PATIENT WAS THEN CONFIRMED 5 WEEKS PREGNANT WITH AN ULTRASOUND. ANOTHER HCG RAPID TEST WITH THE SAME URINE SAMPLE WAS THEN PERFORMED WITH A POSITIVE RESULT. AN UNKNOWN PAIN MEDICATION WAS GIVEN TO THE PATIENT FOR THE ABDOMINAL PAIN AND WAS DISCHARGED THE SAME DAY. THERE WAS NO ADDITIONAL INFORMATION ON THE CURRENT STATUS OF THE PATIENT OR FETUS. TROUBLESHOOTING OCCURRED BY REVIEWING THE EVENT WITH THE CUSTOMER AND TECHNICAL INFORMATION WAS PROVIDED REGARDING POTENTIAL FACTORS. IT WAS ACKNOWLEDGED THAT THE CUSTOMER BELIEVES POTENTIAL FACTORS ARE RELATED TO THE USER NOT PERFORMING THE TEST, OR PERFORMING THE TEST USING THE INCORRECT PATIENT SAMPLE. OTHER POTENTIAL CAUSES WERE DISCUSSED RELATED TO TECHNIQUE, STORAGE, HANDLING, SAMPLE OR A PRODUCT ISSUE, AND LIMITATIONS OF THE TEST. THE PACKAGE INSERT WAS REVIEWED FOR CONFORMANCE AND NO DEVIATIONS WERE NOTED FROM THE INFORMATION PROVIDED.

  Patient problems: No Code Available; No Information

  MAUDE report 9200096 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  (B)(6) 2018: PATIENT PRESENTED TO THE FACILITY FOR A MISSED PERIOD. PATIENT URINE SPECIMEN WAS TESTED ON THE ALERE HCG CASSETTE AND A POSITIVE RESULT WAS OBTAINED. POSITIVE RESULT WAS QUESTIONED AS THE PATIENT HAS A TUBAL LIGATION. CUSTOMER STATES QUANTITATIVE BETA SERUM HCG TESTS WERE PERFORMED, HOWEVER, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. UNSPECIFIED DATES: CUSTOMER OBSERVED AN ADDITIONAL THREE FALSE POSITIVE RESULTS ON THREE SEPARATE PATIENTS WHEN TESTING ON THE ALERE HCG CASSETTE KIT. CUSTOMER STATES QUANTITATIVE BETA SERUM HCG TESTS WERE PERFORMED, HOWEVER, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. THE CUSTOMER WAS NOT ABLE TO PROVIDE FURTHER PATIENT DETAILS. TSS CONFIRMED NO DELAY IN TREATMENT OR ADVERSE OUTCOMES DUE TO FALSE POSITIVE RESULTS ON THE ALERE HCG CASSETTE FOR ANY OF THE PATIENTS. THE CUSTOMER STATED THAT IT IS THEIR PROCEDURE TO PERFORM CONFIRMATORY TESTING WHEN A POSITIVE PREGNANCY RESULT IS INTERPRETED ON THE ALERE HCG CASSETTE. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT POSSIBLE CAUSES FOR UNEXPECTED RESULTS FOCUSING ON PROPER SAMPLING TECHNIQUE, STORAGE CONDITIONS AND PATIENT SPECIFIC FACTORS PER THE PACKAGE INSERT (PI)-NO DEVIATIONS N

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131295 ↗
• MalfunctionSep 25, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT A CUSTOMER RECEIVED A FALSE POSITIVE RESULT WHEN USING AN ALERE HCG CASSETTE. THE RESULTS CONFIRMED VIA QUANT (B)(6) 2017 HCG = <2.39 MIU/MLUSING VITROS 3600. THE CUSTOMER STATED THEIR FACILITY REPORTS PATIENTS AS NOT PREGNANT IF HCG LESS THAN 6.15 MIU/ML. NO OTHER PATIENT INFORMATION WAS RECEIVED. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT THE ISSUE AND POTENTIAL FACTORS PER THE PI, STORAGE, SAMPLING, AND TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114347 ↗
• MalfunctionSep 25, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT A CUSTOMER RECEIVED A FALSE POSITIVE RESULT WHEN USING AN ALERE HCG CASSETTE. THE RESULTS CONFIRMED VIA QUANT (B)(6) 2017 HCG = 3.79 MIU/ML USING VITROS 3600. THE CUSTOMER STATED THEIR FACILITY REPORTS PATIENTS AS NOT PREGNANT IF HCG LESS THAN 6.15 MIU/ML. NO OTHER PATIENT INFORMATION WAS RECEIVED. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT THE ISSUE AND POTENTIAL FACTORS PER THE PI, STORAGE, SAMPLING, AND TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114344 ↗
• MalfunctionOct 5, 2018False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2018. ON (B)(6) 2018, BLOOD WORK WAS PERFORMED ON THE PATIENT AND A BETA HCG QUANTITATIVE RESULT OF 28 MIU/ML WAS RECEIVED. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY FOR A SCHEDULED DILATION AND CURETTAGE (D&C) PROCEDURE. A NON-FIRST MORNING URINE SAMPLE WAS COLLECTED AND AN ALERE HCG CASSETTE PRODUCED A NEGATIVE HCG RESULT. PER THE CUSTOMER, THE PHYSICIAN SUSPECTS THERE WAS A POSSIBLE MISCARRIAGE A FEW MONTHS AGO. THE PATIENT HAS A HISTORY OF PERSISTENT LOW HCG LEVELS AND GESTATIONAL TROPHOBLASTIC DISEASE WITH HETEROPHILIC ANTIBODIES THAT DO NOT CROSS OVER UNTO THE URINE. BASED ON THE NEGATIVE ALERE HCG CASSETTE RESULT, THE PHYSICIAN ELECTED TO POSTPONE THE D&C PROCEDURE FOR ONE WEEK. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER. PER THE CORRESPONDING PACKAGE INSERT, A NUMBER OF CONDITIONS OTHER THAN PREGNANCY, INCLUDING TROPHOBLASTIC DISEASE CAN CAUSE ELEVATED LEVELS OF HCG. THE TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7939689 ↗
• MalfunctionJul 11, 2018False Negative Result; False Negative Result

  THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2018. ON (B)(6) 2018, THE PATIENT ARRIVED AT THE FACILITY TO CONFIRM A PREGNANCY AND START PRENATAL CARE. THE CUSTOMER WAS UNABLE TO PROVIDE THE REASON THE PATIENT BELIEVED SHE WAS PREGNANT. A URINE SAMPLE WAS COLLECTED AND AN HCG ONE STEP PREGNANCY TEST DEVICE PRODUCED A NEGATIVE RESULT. AS THE CUSTOMER EXPECTED A POSITIVE RESULT, A REPEAT TEST WAS PERFORMED USING A CLARITY HCG TEST AND A NEGATIVE HCG RESULT WAS ALSO OBTAINED. TWENTY MINUTES AFTER THESE TWO TESTS, THE CUSTOMER RETESTED THE SAME URINE SAMPLE USING A SECOND HCG ONE STEP PREGNANCY TEST DEVICE AND RECEIVED ANOTHER NEGATIVE RESULT. AN ULTRASOUND WAS PERFORMED ON THE PATIENT AND THE PATIENT WAS DETERMINED TO BE 18 WEEKS PREGNANT. FOLLOWING THE ULTRASOUND, A SECOND URINE SAMPLE WAS COLLECTED AND TESTED USING A THIRD HCG ONE STEP PREGNANCY TEST DEVICE. A POSITIVE HCG RESULT WAS RECEIVED USING THE SECOND URINE SAMPLE. THE CUSTOMER STATED THAT THE PATIENT WAS ALSO BEING TESTED FOR A DRUG SCREEN AS PART OF THEIR NEW PATIENT ENROLLMENT PROCEDURE. PER THE CUSTOMER, THE PATIENT MAY HAVE TAMPERED WITH THE FIRST URINE SAMPLE DUE TO THE URINE DRUG SCREEN. HOWEVER, THE CUSTOMER CANNOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679923 ↗