CARDINAL HEALTH B1077-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 20885380020268), received between Dec 19, 2017 and Mar 11, 2026 — classified as 1 injury, 148 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (122 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 20, 2026Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026False Positive Result

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576097 ↗
• MalfunctionFeb 27, 2026False Positive Result

  THE DISTRIBUTOR REPORTED A CUSTOMER RECEIVED A FALSE POSITIVE HCG RESULT WHILE USING THE CARDINAL HEALTH¿ HCG COMBO RAPID TEST. THE CUSTOMER REPORTED RECEIVING A POSITIVE RESULT WHEN TESTING THE PATIENT'S URINE AND A NEGATIVE RESULT WHEN TESTING THE PATIENT'S SERUM. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474083 ↗
• MalfunctionJan 9, 2026False Positive Result

  THE DISTRIBUTOR REPORTED A CUSTOMER EXPERIENCED FALSE POSITIVE RESULTS WHEN TESTING WITH THE CARDINAL HEALTH HCG COMBO RAPID TEST. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020660 ↗
• MalfunctionNov 6, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING A PATIENT WITH THE CARDINAL HEALTH HCG COMBO RAPID TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL DETAILS FROM THE CUSTOMER, HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491549 ↗
• MalfunctionNov 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER INFORMED THAT "TWO PATIENTS TESTED POSITIVE ON THE TEST EVEN THOUGH THEY ARE NEGATIVE ON A PREGNANCY TEST." NO ADVERSE HEALTH OUTCOMES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2025-00217 FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458466 ↗
• MalfunctionNov 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER INFORMED THAT "TWO PATIENTS TESTED POSITIVE ON THE TEST EVEN THOUGH THEY ARE NEGATIVE ON A PREGNANCY TEST." NO ADVERSE HEALTH OUTCOMES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2025-00218 FOR THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457916 ↗
• MalfunctionAug 19, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING PATIENT SAMPLES WITH THE CARDINAL HEALTH HCG COMBO RAPID TEST. THE DISTRIBUTOR CONFIRMED THAT NO ADVERSE OUTCOMES OCCURRED DUE TO THE FALSE POSITIVE RESULTS. THREE DUE DILIGENCE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843099 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 3 FALSE POSITIVE RESULTS WHILE USING CARDINAL RAPID COMBO HCG TESTS ON 3 PATIENTS. CONFIRMATORY TESTING WAS PERFORMED ON EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDR 2027969-2025-00181 AND 2027969-2025-00182 FOR PATIENTS 1 AND 2 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821912 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 3 FALSE POSITIVE RESULTS WHILE USING CARDINAL RAPID COMBO HCG TESTS ON 3 PATIENTS. CONFIRMATORY TESTING WAS PERFORMED ON EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. MDR 2027969-2025-00182 AND 2027969-2025-00183 FOR PATIENTS 2 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820502 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 3 FALSE POSITIVE RESULTS WHILE USING CARDINAL RAPID COMBO HCG TESTS ON 3 PATIENTS. CONFIRMATORY TESTING WAS PERFORMED ON EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDR 2027969-2025-00181 AND 2027969-2025-00183 FOR PATIENTS 1 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820499 ↗
• MalfunctionAug 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING THREE FALSE POSITIVE HCG RESULTS WHILE USING CARDINAL RAPID HCG COMBO TESTS. SPECIMENS HAD BEEN REDRAWN ON THE INDIVIDUAL PATIENTS AND WAS ABLE TO CONFIRM THROUGH ALTERNATIVE TESTING. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THE EXACT NUMBER OF PATIENTS INVOLVED WAS NOT PROVIDED, THEREFORE 2 MDRS WILL BE FILED. SEE MDR 2027969-2025-00174 FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750951 ↗
• MalfunctionAug 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING THREE FALSE POSITIVE HCG RESULTS WHILE USING CARDINAL RAPID HCG COMBO TESTS. SPECIMENS HAD BEEN REDRAWN ON THE INDIVIDUAL PATIENTS AND WAS ABLE TO CONFIRM THROUGH ALTERNATIVE TESTING. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THE EXACT NUMBER OF PATIENTS INVOLVED WAS NOT PROVIDED, THEREFORE 2 MDRS WILL BE FILED. SEE MDR 2027969-2025-00175 FOR THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750935 ↗
• MalfunctionAug 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING THREE FALSE POSITIVE HCG RESULTS WHILE USING CARDINAL RAPID HCG COMBO TESTS ON THREE PATIENTS. THE CUSTOMER REPORTED THE EVENTS TOOK PLACE ON 10JUL2025, 11JUL2025 AND 12JUL2025, HOWEVER THE CUSTOMER COULD NOT CONFIRM WHICH DATE EACH PATIENT PRESENTED. A SERUM SAMPLE WAS COLLECTED FOR EACH PATIENT WHICH WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. ADDITIONAL SPECIMENS WERE REDRAWN ON THE INDIVIDUAL PATIENTS AND CONFIRMATORY TESTING YIELDED A NEGATIVE RESULT FOR EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDRS 2027969-2025-00172 AND 2027969-2025-00173 FOR PATIENT 2 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741771 ↗
• MalfunctionAug 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING THREE FALSE POSITIVE HCG RESULTS WHILE USING CARDINAL RAPID HCG COMBO TESTS ON THREE PATIENTS. THE CUSTOMER REPORTED THE EVENTS TOOK PLACE ON 10JUL2025, 11JUL2025 AND 12JUL2025, HOWEVER THE CUSTOMER COULD NOT CONFIRM WHICH DATE EACH PATIENT PRESENTED. A SERUM SAMPLE WAS COLLECTED FOR EACH PATIENT WHICH WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. ADDITIONAL SPECIMENS WERE REDRAWN ON THE INDIVIDUAL PATIENTS AND CONFIRMATORY TESTING YIELDED A NEGATIVE RESULT FOR EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDRS 2027969-2025-00171 AND 2027969-2025-00173 FOR PATIENT 1 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741591 ↗
• MalfunctionAug 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING THREE FALSE POSITIVE HCG RESULTS WHILE USING CARDINAL RAPID HCG COMBO TESTS ON THREE PATIENTS. THE CUSTOMER REPORTED THE EVENTS TOOK PLACE ON 10JUL2025, 11JUL2025 AND 12JUL2025, HOWEVER THE CUSTOMER COULD NOT CONFIRM WHICH DATE EACH PATIENT PRESENTED. A SERUM SAMPLE WAS COLLECTED FOR EACH PATIENT WHICH WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. ADDITIONAL SPECIMENS WERE REDRAWN ON THE INDIVIDUAL PATIENTS AND CONFIRMATORY TESTING YIELDED A NEGATIVE RESULT FOR EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDR 2027969-2025-00171 AND 2027969-2025-00172 FOR PATIENT 1 AND 2 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741336 ↗
• MalfunctionAug 5, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER REPORTED RECEIVING 3 FALSE POSITIVE HCG RESULTS WITHIN THE PAST WEEK WHILE USING CARDINAL RAPID COMBO HCG TESTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720009 ↗
• MalfunctionJul 30, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING THE CARDINAL RAPID HCG COMBO TESTS ON A SINGLE PATIENT. THE PATIENT PRESENTED ON (B)(6) 2025 FOR HCG TESTING PRIOR TO UNDERGOING AN UNSPECIFIED ELECTIVE SURGICAL PROCEDURE. A SERUM SAMPLE WAS COLLECTED; THE RESULTS WERE READ AT 5 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. AS A RESULT OF THE POSITIVE HCG TEST RESULT, THE PROCEDURE WAS CANCELLED. CONFIRMATORY BHCG TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. ON (B)(6) 2025 REPEAT TESTING WAS PERFORMED USING THE SAME SAMPLE AND ANOTHER CARDINAL DEVICE FROM THE SAME LOT. REPEAT TESTING YIELDED A POSITIVE HCG RESULT. AN ADDITIONAL CONFIRMATORY BHCG TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. THE SAME SERUM SAMPLE WAS THEN TESTED ON (B)(6) 2025 WITH A DEVICE FROM THE SAME LOT AND A DIFFERENT LOT (LOT NUMBER 0000946166). THE CUSTOMER REPORTED TESTING WITH THE REPEAT LOT YIELDED A POSITIVE HCG RESULT, WHILE TESTING WITH LOT NUMBER 0000946166 YIELDED A NEGATIVE RESULT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671499 ↗
• MalfunctionFeb 11, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE RESULT WHILE USING THE CARDINAL RAPID HCG COMBO TEST. THE PATIENT PRESENTED DUE TO EXCRUCIATING PELVIC REGION PAIN. THE PATIENT PROVIDED A FRESH URINE SAMPLE ON (B)(6) 2025 WHICH APPEARED CLOUDY WITH BLOOD PRESENT. THE SAMPLE WAS CENTRIFUGED AND THEN TESTED USING THE CARDINAL RAPID COMBO TEST. THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. ON (B)(6) 2025, A SERUM SAMPLE WAS COLLECTED AND TESTED USING ANOTHER CARDINAL DEVICE. THE RESULTS WERE READ AT 5 MINUTES AND A NEGATIVE HCG RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS THEN PERFORMED USING THE PATIENT'S PLASMA SAMPLE AND A NEGATIVE HCG RESULT WAS OBTAINED. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360823 ↗
• MalfunctionJan 20, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING THE CARDINAL RAPID HCG COMBO TEST FOR ONE PATIENT. THE CUSTOMER INITIALLY REPORTED THAT MOST OF THE TESTS ARE TAKING OVER 5 MINUTES TO FULLY PRODUCE THE RESULTS. ADDITIONALLY, AS THE TEST IS RUNNING 3 LINES WOULD APPEAR AT FIRST, INSTEAD OF ONLY 2, THEN FINALLY THE TEST WILL SHOW JUST THE FINAL TWO LINES. ALTHOUGH REQUESTED, NO PHOTOS ARE AVAILABLE. THE CUSTOMER REPORTED CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. NEW INFORMATION RECEIVED ON 31JAN2025, CLARIFIED THAT THE CUSTOMER INITIALLY RECEIVED A FALSE POSITIVE HCG RESULT USING THE CARDINAL RAPID HCG COMBO TEST WHEN THE RESULTS WERE READ AT 3 MINUTES. THE RESULT THEN LATER TURNED NEGATIVE AFTER AN UNSPECIFIED TIME. A REPEAT TEST WAS THEN PERFORMED WHICH YIELDED A NEGATIVE RESULT. CONFIRMATORY TESTING WAS THEN PERFORMED ON 5JAN2025 WHICH ALSO YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194207 ↗
• MalfunctionJan 6, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING A PATIENT SAMPLE WITH CARDINAL HEALTH HCG COMBO RAPID TEST. NO SPECIFIC PATIENT INFORMATION COULD BE PROVIDED, HOWEVER THE CUSTOMER STATED THAT THEY USUALLY PERFORM URINE HCG TESTS FOR PATIENTS EXPERIENCING PRESENTING WITH ABDOMINAL PAIN OR PRIOR TO SURGICAL PROCEDURES. THE CUSTOMER NOTED THAT THE SAMPLE APPEARED TO MIGRATE ACROSS THE TEST STRIP SLOWER THAN USUAL, AND THAT THE BACKGROUND DID NOT APPEAR TO HAVE CLEARED AT THE 3-MINUTE MARK, GIVING THE APPEARANCE OF A FAINT LINE IN THE TEST REGION. THE TEST WAS PERFORMED A FOURTH TIME AND THE RESULT WAS NEGATIVE WITH A CLEAR BACKGROUND. NO ADVERSE EVENTS OCCURRED; THE POSITIVE RESULTS WERE NOT REPORTED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21086001 ↗
• MalfunctionNov 18, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING A PATIENT USING THE CARDINAL HEALTH HCG COMBO RAPID TEST. THE PATIENT WAS BEING TESTED PRIOR TO BEING PRESCRIBED DEPO-PROVERA FOR CONTRACEPTION. THE PATIENT HAD GIVEN BIRTH APPROXIMATELY SIX WEEKS PRIOR, AND HAD NOT BEEN SEXUALLY ACTIVE IN THE INTERIM. A BLOOD TEST WAS PERFORMED (METHOD NOT SPECIFIED) AND THE RESULT WAS NEGATIVE. THE FALSE POSITIVE RESULTS LED TO A DELAY OF ONE DAY IN THE PRESCRIPTION OF THE DEPO-PROVERA AND INCONVENIENCE FOR THE PATIENT. THERE WAS NO ADVERSE MEDICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714422 ↗
• MalfunctionNov 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING THE CARDINAL RAPID TEST HCG COMBO ON TWO PATIENTS. THE TWO PATIENTS WERE TESTED FOR PRE-OP SCREENINGS FOR SURGICAL PROCEDURES. THE SECOND PATIENT PROVIDED A FRESH SAMPLE ON (B)(6) 2024 WHICH WAS TESTED AND RESULTED IN A POSITIVE HCG RESULT. THE POSITIVE RESULT WAS NOT EXPECTED SO A CONFIRMATORY BLOOD TEST WAS PERFORMED ON THE SAME DAY WHICH YIELDED A NEGATIVE RESULT. THE PATIENT'S URINE SAMPLE WAS THEN STORED IN REFRIGERATION AND TESTED THE NEXT DAY ((B)(6) 2024) USING CLEARBLUE TEST AND WALGREENS TEST WHICH BOTH YIELDED A NEGATIVE RESULT. AN ADDITIONAL TEST WAS PERFORMED USING A CARDINAL RAPID TEST HCG COMBO DEVICE FROM LOT 0000870050 WHICH ALSO YIELDED A POSITIVE RESULT. NO ADVERSE EVENT REPORTED. SEE 2027969-2024-00198, 2027969-2024-00199 FOR THE 2 ADDITIONAL FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689241 ↗
• MalfunctionNov 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING THE CARDINAL RAPID TEST HCG COMBO ON TWO PATIENTS. THE TWO PATIENTS WERE TESTED FOR PRE-OP SCREENINGS FOR SURGICAL PROCEDURES. THE FIRST PATIENT PROVIDED A FRESH SAMPLE ON (B)(6) 2024 WHICH WAS TESTED AND RESULTED IN A POSITIVE HCG RESULT. THE POSITIVE RESULT WAS NOT EXPECTED SO A CONFIRMATORY BLOOD TEST WAS PERFORMED ON THE SAME DAY WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENT REPORTED. SEE 2027969-2024-00199, 2027969-2024-00200 FOR THE 2 ADDITIONAL FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688945 ↗
• MalfunctionNov 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING THE CARDINAL RAPID TEST HCG COMBO ON TWO PATIENTS. THE TWO PATIENTS WERE TESTED FOR PRE-OP SCREENINGS FOR SURGICAL PROCEDURES. THE SECOND PATIENT PROVIDED A FRESH SAMPLE ON (B)(6) 2024 WHICH WAS TESTED AND RESULTED IN A POSITIVE HCG RESULT. THE POSITIVE RESULT WAS NOT EXPECTED SO A CONFIRMATORY BLOOD TEST WAS PERFORMED ON THE SAME DAY WHICH YIELDED A NEGATIVE RESULT. THE PATIENT'S URINE SAMPLE WAS THEN STORED IN REFRIGERATION AND TESTED THE NEXT DAY ( (B)(6) 2024) USING CLEARBLUE TEST AND WALGREENS TEST WHICH BOTH YIELDED A NEGATIVE RESULT. AN ADDITIONAL TEST WAS PERFORMED USING A CARDINAL RAPID TEST HCG COMBO DEVICE FROM LOT 0000870050 WHICH ALSO YIELDED A POSITIVE RESULT. NO ADVERSE EVENT REPORTED. SEE 2027969-2024-00198, 2027969-2024-00200 FOR THE 2 ADDITIONAL FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688576 ↗
• MalfunctionOct 3, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING A PATIENT WITH THE CARDINAL HEALTH HCG COMBO RAPID TEST. THE PATIENT HAD PREVIOUSLY UNDERGONE A HYSTERECTOMY. THE CUSTOMER STATED THAT THE STAFF RAN MULTIPLE TESTS WITH LOT 0000673604 AND COMPARED THE RESULTS TO ANOTHER LOT (LOT NUMBER NOT PROVIDED) AND ALL RESULTS FROM LOT 0000673604 WERE POSITIVE. THREE ATTEMPTS WERE MADE TO GATHER ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364389 ↗