CARDINAL HEALTH B1077-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 20885380020251), received between Apr 27, 2017 and Mar 12, 2026 — classified as 6 injuries, 38 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (32 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-3274-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A FAINT POSITIVE HCG RESULT WHILE USING THE CARDINAL HEALTH¿ HCG CASSETTE RAPID TEST ON A PATIENT. THE RESULT WAS READ AT 3 MINUTES AND A FAINT POSITIVE RESULT WAS OBTAINED. THE CUSTOMER REPORTED THE TEST LINE TENDS TO FADE BY APPROXIMATELY 4 MINUTES. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587132 ↗
• MalfunctionAug 4, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING THE CARDINAL HEALTH¿ HCG CASSETTE RAPID TEST. THE PATIENT PRESENTED DUE TO ABDOMINAL PAIN AND NAUSEA. A URINE SAMPLE WAS COLLECTED, TESTED AND THE RESULTS WERE READ AT 3 MINUTES AND 2 SECONDS. A FAINT POSITIVE HCG RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED USING ANOTHER DEVICE FROM THE SAME LOT AND A NEGATIVE HCG RESULT WAS OBTAINED. THE CUSTOMER THEN PERFORMED CONFIRMATORY BETA HCG SERUM TESTING WHICH YIELDED A NEGATIVE HCG RESULT OF 2 MIU/ML. THE PATIENT WAS ADVISED TO HAVE ADDITIONAL BETA HCG TESTING PERFORMED IN TWO WEEKS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710191 ↗
• MalfunctionJun 2, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING A FALSE NEGATIVE HCG RESULT WHILE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TEST. THE PATIENT PROVIDED A URINE SAMPLE WHICH WAS TESTED AT 20:02. THE RESULTS WERE READ AT 4 MINUTES A NEGATIVE HCG RESULT WAS OBTAINED. A CONFIRMATORY QUANTITATIVE BETA HCG TEST WAS PERFORMED WHICH YIELDED A POSITIVE RESULT OF 269MIU/ML. AFTERWARDS, AN ADDITIONAL CARDINAL DEVICE FROM THE SAME KIT WAS TESTED USING THE SAME SAMPLE, AND A POSITIVE HCG RESULT WAS OBTAINED. NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126432 ↗
• MalfunctionApr 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 4 FALSE POSITIVE HCG RESULTS USING CARDINAL RAPID HCG TEST CASSETTES FOR 4 PATIENTS. IT WAS REPORTED THAT THESE EVENTS TOOK PLACE SOMETIME AROUND THE WEEK OF (B)(6) 2025, HOWEVER SPECIFICS WERE UNAVAILABLE. THE THIRD PATIENT PRESENTED FOR A ROUTINE POST-PARTUM CHECK-UP. THE PATIENT WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. A RETEST WAS PERFORMED USING ANOTHER DEVICE FROM THE SAME KIT WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENT REPORTED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2025-00082 AND 2027969-2025-00083 FOR PATIENT 1 AND 2 RESPECTIVELY. THE POSITIVE RESULT OBTAINED BY THE FOURTH PATIENT HAS BEEN DEEMED NOT REPORTABLE AS THE CUSTOMER DEVIATED FROM THE PACKAGE INSERT, THEREFORE A PRODUCT MALFUNCTION WAS NOT DETERMINED, AND NO ADVERSE EVENTS WERE REPORTED. THEREFORE ONLY 3 MDRS ARE BEING FILED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758851 ↗
• MalfunctionApr 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 4 FALSE POSITIVE HCG RESULTS USING CARDINAL RAPID HCG TEST CASSETTES FOR 4 PATIENTS. IT WAS REPORTED THAT THESE EVENTS TOOK PLACE SOMETIME AROUND THE WEEK OF (B)(6) 2025, HOWEVER SPECIFICS WERE UNAVAILABLE. THE SECOND PATIENT PRESENTED FOR AN UNSPECIFIED REASON. THE PATIENT WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. A RETEST WAS PERFORMED USING ANOTHER DEVICE FROM THE SAME KIT WHICH YIELDED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00082 AND 2027969-2025-00084 FOR PATIENT 1 AND 3 RESPECTIVELY. THE POSITIVE RESULT OBTAINED BY THE FOURTH PATIENT HAS BEEN DEEMED NOT REPORTABLE AS THE CUSTOMER DEVIATED FROM THE PACKAGE INSERT, THEREFORE A PRODUCT MALFUNCTION WAS NOT DETERMINED, AND NO ADVERSE EVENTS WERE REPORTED. THEREFORE ONLY 3 MDRS ARE BEING FILED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758681 ↗
• MalfunctionApr 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 4 FALSE POSITIVE HCG RESULTS USING CARDINAL RAPID HCG TEST CASSETTES FOR 4 PATIENTS. IT WAS REPORTED THAT THESE EVENTS TOOK PLACE SOMETIME AROUND THE WEEK OF (B)(6) 2025, HOWEVER SPECIFICS WERE UNAVAILABLE. THE FIRST PATIENT PRESENTED FOR AN IUD INSERTION PROCEDURE. THE PATIENT WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT WAS ADAMANT THEY WERE NOT PREGNANT AS THEY WERE NOT SEXUALLY ACTIVE, AND THEY HAD RECENTLY FINISHED A MENSTRUAL CYCLE. A RETEST WAS PERFORMED USING ANOTHER DEVICE FROM THE SAME KIT WHICH YIELDED A NEGATIVE RESULT. THE IUD PROCEDURE WAS PERFORMED, AND NO ADVERSE EVENTS WERE REPORTED. SEE MDR 2027969-2025-00083 AND 2027969-2025-00084 FOR PATIENT 2 AND 3 RESPECTIVELY. THE POSITIVE RESULT OBTAINED BY THE FOURTH PATIENT HAS BEEN DEEMED NOT REPORTABLE AS THE CUSTOMER DEVIATED FROM THE PACKAGE INSERT, THEREFORE A PRODUCT MALFUNCTION WAS NOT DETERMINED, AND NO ADVERSE EVENTS WERE REPORTED. THEREFORE ONLY 3 MDRS ARE BEING FILED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757933 ↗
• MalfunctionOct 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TEST. THE TEST WAS PERFORMED WITH THREE ADDITIONAL LOT NUMBERS, EACH TIME YIELDING A POSITIVE RESULT. A BLOOD TEST WAS SUBSEQUENTLY PERFORMED AND YIELDED A NEGATIVE RESULT. THE PATIENT EXPERIENCE EMOTIONAL DISTRESS OVER THE POSITIVE RESULTS, HOWEVER THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED TO ADDRESS THE DISTRESS. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517129 ↗
• MalfunctionOct 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TEST. THE TEST WAS PERFORMED WITH THREE ADDITIONAL LOT NUMBERS, EACH TIME YIELDING A POSITIVE RESULT. A BLOOD TEST WAS SUBSEQUENTLY PERFORMED AND YIELDED A NEGATIVE RESULT. THE PATIENT EXPERIENCED EMOTIONAL DISTRESS OVER THE POSITIVE RESULTS, HOWEVER THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED TO ADDRESS THE DISTRESS. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516914 ↗
• MalfunctionOct 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TEST. THE TEST WAS PERFORMED WITH THREE ADDITIONAL LOT NUMBERS, EACH TIME YIELDING A POSITIVE RESULT. A BLOOD TEST WAS SUBSEQUENTLY PERFORMED AND YIELDED A NEGATIVE RESULT. THE PATIENT EXPERIENCED EMOTIONAL DISTRESS OVER THE POSITIVE RESULTS, HOWEVER THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED TO ADDRESS THE DISTRESS. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516268 ↗
• MalfunctionOct 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TEST. THE TEST WAS PERFORMED WITH THREE ADDITIONAL LOT NUMBERS, EACH TIME YIELDING A POSITIVE RESULT. A BLOOD TEST WAS SUBSEQUENTLY PERFORMED AND YIELDED A NEGATIVE RESULT. THE PATIENT EXPERIENCED EMOTIONAL DISTRESS OVER THE POSITIVE RESULTS, HOWEVER THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED TO ADDRESS THE DISTRESS. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516083 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 2 FALSE POSITIVE RESULTS FOR 2 PATIENTS WHILE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TESTS. THE CUSTOMER REPORTED THE FOLLOWING "IN THE SAINT POSITIVE LINES WHEN THEY ARE PUTTING A SERUM IT IS GETTING NEGATIVE." ATTEMPTS TO CLARIFY THIS STATEMENT AND TO GATHER ADDITIONAL INFORMATION WAS PERFORMED HOWEVER THE CUSTOMER WAS UNRESPONSIVE. IT IS UNCLEAR FROM THE INFORMATION PROVIDED, HOWEVER PLEASE NOTE, HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AID IN THE EARLY DETECTION OF PREGNANCY. THIS SPECIFIC TEST IS NOT DESIGNED FOR USE WITH SERUM SAMPLES. NO ADVERSE EVENTS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR # 2027969-2024-00109 FOR THE FIRST PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19966372 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 2 FALSE POSITIVE RESULTS FOR 2 PATIENTS WHILE USING THE CARDINAL HEALTH HCG CASSETTE RAPID TESTS. THE CUSTOMER REPORTED THE FOLLOWING "IN THE SAINT POSITIVE LINES WHEN THEY ARE PUTTING A SERUM IT IS GETTING NEGATIVE." ATTEMPTS TO CLARIFY THIS STATEMENT AND TO GATHER ADDITIONAL INFORMATION WAS PERFORMED HOWEVER THE CUSTOMER WAS UNRESPONSIVE. IT IS UNCLEAR FROM THE INFORMATION PROVIDED, HOWEVER PLEASE NOTE, HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AID IN THE EARLY DETECTION OF PREGNANCY. THIS SPECIFIC TEST IS NOT DESIGNED FOR USE WITH SERUM SAMPLES. NO ADVERSE EVENTS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR # 2027969-2024-00110 FOR THE SECOND PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19966044 ↗
• InjuryJul 26, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH THE CARDINAL HCG CASSETTE RAPID TEST. FOLLOWING THE NEGATIVE RESULT, THE PATIENT WAS SENT FOR A CT SCAN AND IT WAS DETERMINED THAT THE PATIENT HAD APPENDICITIS. THE PATIENT WAS SENT TO THE ER WHERE LABS WERE COMPLETED WITH A RESULT OF 151 MIU/ML; THE PATIENT WAS DETERMINED TO BE PREGNANT. NO ADVERSE OUTCOMES WERE REPORTED AS A RESULT OF THE CT SCAN, HOWEVER DUE TO THE POTENTIAL FOR DAMAGE TO THE FETUS THIS WILL BE CONSIDERED AN OTHER SERIOUS/IMPORTANT MEDICAL EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840907 ↗
• MalfunctionMay 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FIVE FALSE POSITIVE HCG RESULTS ON CARDINAL RAPID TEST HCG CASSETTES WHILE TESTING FIVE PATIENTS. EACH PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR AN UNSPECIFIED REASON. A SERUM SAMPLE WAS COLLECTED FROM "PATIENT 5" ON (B)(6) 2024 AT 1020 AND NO VISIBLE ANOMALIES WERE OBSERVED REGARDING THE SAMPLE APPEARANCE. THE CUSTOMER REPORTED A TIMER WAS USED, THE TEST WAS PERFORMED PER THE PACKAGE INSERT AND FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE BETA HCG RESULT. NO ADVERSE EVENTS WERE REPORTED; HOWEVER, EACH PATIENT EXPERIENCED A 1-2 HOUR DELAY AS CONFIRMATORY TESTING WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2024-00050, 2027969-2024-00051, 2027969-2024-00052 AND 2027969-2024-00053 FOR THE OTHER RELATED PATIENTS. UPON FURTHER REVIEW IT WAS NOTED THAT INITIAL EMDRS WERE NOT REQUIRED AS THE CUSTOMER USED AN INCORRECT SAMPLE TYPE (SERUM) AND NO ADVERSE EVENTS WERE REPORTED. ACCORDING TO THE PACKAGE INSERT, THE HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AID IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256070 ↗
• MalfunctionMay 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF (B)(4) FALSE POSITIVE HCG RESULTS ON CARDINAL RAPID TEST HCG CASSETTES WHILE TESTING FIVE PATIENTS. EACH PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR AN UNSPECIFIED REASON. A SERUM SAMPLE WAS COLLECTED FROM "PATIENT(B)(6) ON (B)(6) 2024 AT 1619 AND NO VISIBLE ANOMALIES WERE OBSERVED REGARDING THE SAMPLE APPEARANCE. THE CUSTOMER REPORTED A TIMER WAS USED, THE TEST WAS PERFORMED PER THE PACKAGE INSERT AND FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE BETA HCG RESULT. NO ADVERSE EVENTS WERE REPORTED; HOWEVER, EACH PATIENT EXPERIENCED A 1-2 HOUR DELAY AS CONFIRMATORY TESTING WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2024-00050, 2027969-2024-00051, 2027969-2024-00052 AND 2027969-2024-00054 FOR THE OTHER RELATED PATIENTS. UPON FURTHER REVIEW IT WAS NOTED THAT INITIAL EMDRS WERE NOT REQUIRED AS THE CUSTOMER USED AN INCORRECT SAMPLE TYPE (SERUM) AND NO ADVERSE EVENTS WERE REPORTED. ACCORDING TO THE PACKAGE INSERT, THE HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256061 ↗
• MalfunctionMay 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FIVE FALSE POSITIVE HCG RESULTS ON CARDINAL RAPID TEST HCG CASSETTES WHILE TESTING FIVE PATIENTS. EACH PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR AN UNSPECIFIED REASON. A SERUM SAMPLE WAS COLLECTED FROM "PATIENT 3" ON (B)(6) 2024 AT 1120 AND NO VISIBLE ANOMALIES WERE OBSERVED REGARDING THE SAMPLE APPEARANCE. THE CUSTOMER REPORTED A TIMER WAS USED, THE TEST WAS PERFORMED PER THE PACKAGE INSERT AND FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE BETA HCG RESULT. NO ADVERSE EVENTS WERE REPORTED; HOWEVER, EACH PATIENT EXPERIENCED A 1-2 HOUR DELAY AS CONFIRMATORY TESTING WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2024-00050, 2027969-2024-00051, 2027969-2024-00053 AND 2027969-2024-00054 FOR THE OTHER RELATED PATIENTS. UPON FURTHER REVIEW IT WAS NOTED THAT INITIAL EMDRS WERE NOT REQUIRED AS THE CUSTOMER USED AN INCORRECT SAMPLE TYPE (SERUM) AND NO ADVERSE EVENTS WERE REPORTED. ACCORDING TO THE PACKAGE INSERT, THE HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AID IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256005 ↗
• MalfunctionMay 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF (B)(4) FALSE POSITIVE HCG RESULTS ON CARDINAL RAPID TEST HCG CASSETTES WHILE TESTING FIVE PATIENTS. EACH PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR AN UNSPECIFIED REASON. A SERUM SAMPLE WAS COLLECTED FROM "PATIENT 2" ON (B)(6) 2024 AT 0845 AND NO VISIBLE ANOMALIES WERE OBSERVED REGARDING THE SAMPLE APPEARANCE. THE CUSTOMER REPORTED A TIMER WAS USED, THE TEST WAS PERFORMED PER THE PACKAGE INSERT AND FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE BETA HCG RESULT. NO ADVERSE EVENTS WERE REPORTED; HOWEVER, EACH PATIENT EXPERIENCED A 1-2 HOUR DELAY AS CONFIRMATORY TESTING WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2024-00050, 2027969-2024-00052, 2027969-2024-00053 AND 2027969-2024-00054 FOR THE OTHER RELATED PATIENTS. UPON FURTHER REVIEW IT WAS NOTED THAT INITIAL EMDRS WERE NOT REQUIRED AS THE CUSTOMER USED AN INCORRECT SAMPLE TYPE (SERUM) AND NO ADVERSE EVENTS WERE REPORTED. ACCORDING TO THE PACKAGE INSERT, THE HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AID I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255984 ↗
• MalfunctionMay 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FIVE FALSE POSITIVE HCG RESULTS ON CARDINAL RAPID TEST HCG CASSETTES WHILE TESTING FIVE PATIENTS. EACH PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR AN UNSPECIFIED REASON. A SERUM SAMPLE WAS COLLECTED FROM "PATIENT 1" ON (B)(6) 2024 AT 1930 AND NO VISIBLE ANOMALIES WERE OBSERVED REGARDING THE SAMPLE APPEARANCE. THE CUSTOMER REPORTED A TIMER WAS USED, THE TEST WAS PERFORMED PER THE PACKAGE INSERT AND FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE BETA HCG RESULT. NO ADVERSE EVENTS WERE REPORTED; HOWEVER, EACH PATIENT EXPERIENCED A 1-2 HOUR DELAY AS CONFIRMATORY TESTING WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2024-00051, 2027969-2024-00052, 2027969-2024-00053 AND 2027969-2024-00054 FOR THE OTHER RELATED PATIENTS. UPON FURTHER REVIEW IT WAS NOTED THAT INITIAL EMDRS WERE NOT REQUIRED AS THE CUSTOMER USED AN INCORRECT SAMPLE TYPE (SERUM) AND NO ADVERSE EVENTS WERE REPORTED. ACCORDING TO THE PACKAGE INSERT, THE HCG CASSETTE RAPID TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE TO AID IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255975 ↗
• MalfunctionOct 4, 2023False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED AN ISSUE WITH TWO CARDINAL HEALTH HCG CASSETTE RAPID TESTS. A PATIENT SAMPLE WAS TESTED AND YIELDED A FAINT POSITIVE RESULT. THE TEST WAS REPEATED WITH A NEGATIVE RESULT. ANOTHER TEST WAS PERFORMED (METHOD NOT SPECIFIED) AND THE RESULT WAS NEGATIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873794 ↗
• InjuryJul 5, 2023False Negative Result; False Negative Result

  THE DISTRIBUTOR REPORTED AN UNSPECIFIED NUMBER OF FALSE NEGATIVE RESULTS WHEN TESTING PATIENT SAMPLES USING THE HCG CASSETTE RAPID TEST, BUT WAS ONLY ABLE TO PROVIDE INFORMATION FOR ONE PATIENT. THE PATIENT WAS TESTED AS A SCREEN PRIOR TO RECEIVING A DEPO-PROVERA INJECTION FOR CONTRACEPTION. THE PATIENT TESTED NEGATIVE ON THE HCG CASSETTE RAPID TEST AND RECEIVED THE DEPO-PROVERA INJECTION. AN UNSPECIFIED URINE PREGNANCY TEST WAS PERFORMED AT ANOTHER CLINIC 26 DAYS LATER WITH A POSITIVE RESULT. A QUANTITATIVE BLOOD HCG TEST WAS PERFORMED THE FOLLOWING DAY WITH A RESULT OF 41,863 (UNITS NOT SPECIFIED), AND THE PATIENT WAS DIAGNOSED AS PREGNANT. THE PATIENT'S PROGESTERONE WAS DETERMINED TO BE LOW (5.8, UNITS NOT SPECIFIED); THE PATIENT WAS PRESCRIBED 200 MG PROGESTERONE PER DAY.

  Patient problems: Hormonal Imbalance

  MAUDE report 17263530 ↗
• InjuryMay 2, 2023False Negative Result; False Negative Result

  THE DISTRIBUTOR REPORTED AN UNSPECIFIED NUMBER OF FALSE NEGATIVE RESULTS WHEN TESTING PATIENT SAMPLES USING THE HCG CASSETTE RAPID TEST, BUT WAS ONLY ABLE TO PROVIDE INFORMATION FOR ONE PATIENT. THE PATIENT WAS TESTED AS A SCREEN PRIOR TO RECEIVING A DEPO-PROVERA INJECTION FOR CONTRACEPTION. THE PATIENT TESTED NEGATIVE ON THE HCG CASSETTE RAPID TEST AND RECEIVED THE DEPO-PROVERA INJECTION. AN UNSPECIFIED URINE PREGNANCY TEST WAS PERFORMED AT ANOTHER CLINIC 26 DAYS LATER WITH A POSITIVE RESULT. A QUANTITATIVE BLOOD HCG TEST WAS PERFORMED THE FOLLOWING DAY WITH A RESULT OF 41,863 (UNITS NOT SPECIFIED), AND THE PATIENT WAS DIAGNOSED AS PREGNANT. THE PATIENT'S PROGESTERONE WAS DETERMINED TO BE LOW (5.8, UNITS NOT SPECIFIED); THE PATIENT WAS PRESCRIBED 200 MG PROGESTERONE PER DAY.

  Patient problems: Hormonal Imbalance

  MAUDE report 16857706 ↗
• MalfunctionFeb 16, 2022False Positive Result; False Positive Result

  ON (B)(6) 2022: FALSE POSITIVE RESULT ON THE CARDINAL HEALTH RAPID TEST HCG CASSETTE KIT USING A FRESH URINE SAMPLE. THE TEST WAS PERFORMED TO RULE OUT PREGNANCY RELATIVE TO THE PATIENT SYMPTOMS. CONFIRMATORY TESTING PERFORMED ON THE ABBOTT I-STAT ANALYZER PROVIDED A NEGATIVE RESULT OF <5 MIU/ML. QUALITY CONTROLS WERE TESTED ON THE KIT LOT WITH NO ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 13544232 ↗
• MalfunctionFeb 8, 2022Incorrect, Inadequate or Imprecise Result or Readings

  CONTROL TESTING PERFORMED ON THE HCG URINE CASSETTE RAPID TEST FOUND THAT SOME OF THE KITS FROM LOT NUMBER HCG1022010 GOT A POSITIVE RESULT ON A NEGATIVE CONTROL. (SOME FROM THIS LOT DID HAVE ACCEPTABLE QUALITY CONTROL RESULTS.) THIS TESTING WAS CONTROL TESTING ONLY. INTERNAL RECALL OF LOT NUMBER HCG1022010 CONDUCTED AND VENDOR CONTACTED DIRECTLY REGARDING ISSUE. SAMPLES FROM AFFECTED LOT WILL BE SENT VENDOR FOR INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 13479725 ↗
• MalfunctionNov 30, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021: FAINT FALSE POSITIVE RESULT ON CARDINAL HEALTH RAPID TEST KIT LOT HCG1012011. CUSTOMER RETESTED THE SAME SAMPLE WITH AN ALTERNATE LOT OF CARDINAL HEALTH RAPID TEST KIT AND OBTAINED A NEGATIVE RESULT. CUSTOMER ALLEGES THE NEGATIVE RESULT IS THE ACCURATE RESULT. NO ADVERSE OUTCOMES OCCURRED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12900939 ↗
• MalfunctionNov 30, 2021False Positive Result; False Positive Result

  (B)(6) 2021: FAINT FALSE POSITIVE RESULT ON CARDINAL HEALTH RAPID TEST KIT LOT HCG1012010. CUSTOMER RETESTED THE SAME SAMPLE WITH AN ALTERNATE LOT OF CARDINAL HEALTH RAPID TEST KIT AND OBTAINED A NEGATIVE RESULT. CUSTOMER ALLEGES THE NEGATIVE RESULT IS THE ACCURATE RESULT. NO ADVERSE OUTCOMES OCCURRED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12900841 ↗