McKesson 5002Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 20612479202768), received between Jul 17, 2017 and Sep 24, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (20 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1587-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891323 ↗
• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677983 ↗
• MalfunctionSep 8, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677972 ↗
• MalfunctionMar 30, 2026False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG COMBO CASSETTE. A SERUM SAMPLE WAS COLLECTED AND A QUANTITATIVE TEST WAS PERFORMED WITH A RESULT OF 25.9 MIU/ML. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT'S HEALTH DUE TO THE FALSE NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716927 ↗
• MalfunctionMar 5, 2026False Negative Result

  THE CUSTOMER REPORTED RECEIVING A FALSE NEGATIVE HCG RESULT WHILE USING THE MCKESSON CONSULT® DIAGNOSTICS HCG COMBO TEST CASSETTE. THE PATIENT PROVIDED A URINE SAMPLE WHICH WAS TESTED AND THE RESULTS WERE READ AT 3 MINUTES. A FALSE NEGATIVE HCG RESULT WAS OBTAINED. CONFIRMATORY QUANTITATIVE TESTING WAS PERFORMED WHICH YIELDED A POSITIVE RESULT OF 21 MIU/ML. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THE CUSTOMER ALSO MENTIONED ANOTHER PATIENT RECEIVED A FALSE POSITIVE HCG RESULT. SEE MDR 2027969-2026-00033 FOR THAT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525231 ↗
• MalfunctionMar 5, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING THE MCKESSON CONSULT® DIAGNOSTICS HCG COMBO TESTS CASSETTE. THE PATIENT PROVIDED A URINE SAMPLE WHICH WAS TESTED AND THE RESULTS WERE READ AT 3 MINUTES. A FAINT FALSE POSITIVE HCG RESULT WAS OBTAINED. CONFIRMATORY QUANTITATIVE TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT OF 1.4 MIU/ML. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THE CUSTOMER ALSO MENTIONED ANOTHER PATIENT RECEIVED A FALSE NEGATIVE HCG RESULT. MDR 2027969-2026-00034 FOR THAT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525128 ↗
• MalfunctionJan 27, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG COMBO CASSETTE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192843 ↗
• MalfunctionJan 27, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG COMBO CASSETTE. THE PATIENT WAS NOT SEXUALLY ACTIVE. BLOOD HCG TESTING WAS PERFORMED WITH A NEGATIVE RESULT. THE PATIENT EXPERIENCED A DELAY IN RECEIVING BIRTH CONTROL MEDICATION AND SOME ANXIETY AS A RESULT OF THE FALSE POSITIVE. NO TREATMENT WAS REQUIRED TO ADDRESS THE PATIENT'S ANXIETY, AND NO ADVERSE HEALTH IMPACT WAS REPORTED.

  Patient problems: Anxiety

  MAUDE report 24192757 ↗
• MalfunctionMar 8, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING THE CONSULT HCG URINE/SERUM COMBO DEVICE. THE CUSTOMER INDICATED THE PATIENT PRESENTED DUE TO NAUSEA SYMPTOMS. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH POSSIBLY CONTAINED TRACE BLOOD, 1+ LEUKOCYTES. THE SAMPLE WAS ALLOWED TO EQUILIBRATE TO ROOM TEMPERATURE AND 3 DROPS OF URINE WAS APPLIED TO THE DEVICE. THE RESULTS WERE READ AT THREE MINUTES (USING A TIMER) AND THE CUSTOMER INDICATED A POSITIVE RESULT WAS OBSERVED. THE PATIENT WAS TESTED TWO ADDITIONAL TIMES USING THE SAME SAMPLE AND ADDITIONAL DEVICES FROM THE SAME LOT NUMBER AND TWO FAINT POSITIVE RESULTS WERE OBSERVED. A QUANTITATIVE HCG TEST WAS PERFORMED USING VENOUS BLOOD WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867349 ↗
• MalfunctionOct 27, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING A FALSE NEGATIVE HCG RESULT WHILE USING THE CONSULT HCG COMBO TEST. THE CUSTOMER REPORTED THE PATIENT PRESENTED TO THE HOSPITAL DUE TO VAGINAL BLEEDING. A FRESH URINE SAMPLE WAS COLLECTED WHICH THE CUSTOMER REPORTED YIELDED A NEGATIVE RESULT. ADDITIONALLY, A CATHETER URINE SAMPLE AND SERUM SAMPLE WERE COLLECTED USING THE CONSULT HCG COMBO TEST AND POSITIVE HCG RESULTS WERE OBTAINED. IT WAS NOT SPECIFIED WHEN THE PATIENT WENT INTO LABOR, HOWEVER IT WAS REPORTED THAT THE PATIENT GAVE BIRTH ON THE SAME DAY. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18025022 ↗
• MalfunctionAug 18, 2022False Positive Result; False Positive Result

  ON (B)(6) 2022: PATIENT PRESENTED TO THE FACILITY TO START BIRTH CONTROL. A SERUM SAMPLE WAS TESTED ON THE CONSULT HCG URIN/SRM COMBO CASSETTE KIT AND A FAINT FALSE POSITIVE RESULT WAS OBTAINED. PATIENT SAMPLE WAS SENT TO LABCORP FOR CONFIRMATORY TESTING. METHODOLOGY OF CONFIRMATORY TESTING AND RESULT NOT PROVIDED. NO TREATMENT WAS PROVIDED OR WITHHELD DUE TO THE FALSE POSITIVE RESULT. NO ADVERSE OUTCOMES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255067 ↗
• MalfunctionSep 30, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT 2 FALSE POSITIVE RESULTS OCCURRED USING THE CONSULT HCG URINE/SERUM COMBO TEST. A PATIENT WITH BREAST TENDERNESS PROVIDED A URINE SAMPLE ON (B)(6) 2021 WHICH WAS USED ON (B)(6) 2021. ALSO ON (B)(6) 2021, A SAME DAY BLOOD SAMPLE WAS DRAWN AND THE HCG LAB RESULT WAS NEGATIVE (<1MIU/ML) USING A SIEMENS DIMENSION VISTA INSTRUMENT. THE QUALITY CONTROLS WERE RUN ON (B)(6) 2021 AND PERFORMED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554952 ↗
• MalfunctionSep 30, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021: A PATIENT HAVING IRREGULAR MENSTRUATION PROVIDED A URINE SAMPLE THAT HAD 2 FALSE POSITIVE RESULTS ON THE CONSULT HCG URINE/SERUM COMBO TEST. A TRANSVAGINAL ULTRASOUND WAS PERFORMED CONFIRMING THE PATIENT WAS NOT PREGNANT. THE QUALITY CONTROLS WERE RUN ON (B)(6) 2021 AND PERFORMED AS EXPECTED. THERE WAS NO REPORT OF AN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554922 ↗
• MalfunctionSep 30, 2021False Positive Result; False Positive Result

  (B)(6) 2021: A PATIENT WITH BREAST TENDERNESS WAS ADMINISTERED THE CONSULT HCG URINE/SERUM COMBO TEST AND HAD 2 FALSE POSITIVE RESULTS WITH A URINE SAMPLE. IT WAS NOT COMPATIBLE WITH THE CLINICAL PICTURE OF THE PATIENT, THEREFORE A BLOOD SAMPLE WAS DRAWN AND THE HCG LAB RESULT WAS NEGATIVE (<1MIU/ML) USING A SIEMENS DIMENSION VISTA INSTRUMENT. THE QUALITY CONTROLS WERE RUN ON 09/07/2021 AND PERFORMED AS EXPECTED. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554865 ↗
• MalfunctionSep 29, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021: A FALSE POSITIVE RESULT OCCURRED WITH A URINE SAMPLE USING THE CONSULT HCG URINE/SERUM COMBO TEST WHEN ADMINISTERED TO A PATIENT FOR POST-PARTUM CONTRACEPTION. THE SAMPLE WAS RETESTED ON A DIFFERENT LOT OF CONSULT HCG URINE PREGNANCY TEST WITH A NEGATIVE RESULT. THE PATIENT WAS DETERMINED NOT TO BE PREGNANT. THE QUALITY CONTROLS WERE RUN ON (B)(6) 2021 AND PERFORMED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550750 ↗
• MalfunctionSep 29, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021: A PATIENT THAT HAD PAIN PROVIDED A URINE SAMPLE WHICH WAS TESTED ON THE CONSULT HCG URINE/SERUM COMBO TEST AND A FALSE POSITIVE RESULT OCCURRED. THE SAMPLE WAS RETESTED ON A DIFFERENT LOT OF THE SAME DEVICE WITH A NEGATIVE RESULT. THE PATIENT WAS DETERMINED TO BE NOT PREGNANT. NO CONFIRMATORY LAB TESTING OCCURRED. THE QUALITY CONTROLS WERE RUN ON (B)(6) 2021 AND PERFORMED AS EXPECTED. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO THE FALSE POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550733 ↗
• MalfunctionSep 29, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021: A PATIENT WITH AN APPOINTMENT FOR AN IUD PLACEMENT HAD A FALSE POSITIVE RESULT WITH A URINE SAMPLE WHEN USING THE CONSULT HCG URINE/SERUM COMBO TEST. THE RESULTS DID NOT COINCIDE WITH THE PATIENT'S CLINICAL PICTURE THEREFORE A SAME DAY BLOOD SAMPLE WAS DRAWN AND THE HCG LAB RESULT WAS NEGATIVE (<1MIU/ML) USING A SIEMENS DIMENSION VISTA INSTRUMENT. THE QUALITY CONTROLS WERE RUN ON (B)(6) 2021 AND PERFORMED AS EXPECTED. THERE WAS NO REPORT OF AN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550721 ↗
• MalfunctionAug 5, 2020False Negative Result; False Negative Result

  UNSPECIFIED DATE: FALSE NEGATIVE RESULT ON THE CONSULT DIAGNOSTICS HCG URINE/SERUM COMBO CASSETTE KIT. NO ADVERSE PATIENT OUTCOMES REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370900 ↗
• MalfunctionAug 5, 2020False Negative Result; False Negative Result

  UNSPECIFIED DATE: FALSE NEGATIVE RESULT ON THE CONSULT DIAGNOSTICS HCG URINE/SERUM COMBO CASSETTE KIT. NO ADVERSE PATIENT OUTCOMES REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370899 ↗
• MalfunctionApr 28, 2020False Positive Result; False Positive Result

  (B)(6) 2020: A (B)(6) OLD FEMALE PATIENT VISITED THE CLINIC "SEEKING PREGNANCY". THE PATIENT'S URINE WAS TESTED ON THE CONSULT DIAGNOSTICS HCG COMBO CASSETTE AT 13:00, WHICH PROVIDED A POSITIVE RESULT. THE SAME SAMPLE WAS RE-TESTED AT 14:30 AND PROVIDED A NEGATIVE RESULT. THE PATIENTS' BLOOD WAS DRAWN FOR A CONFIRMATORY BETA HCG. CONFIRMATORY BETA HCG PROVIDED A NEGATIVE RESULT OF <2.39 MIU/ML. PATIENT IS NOT PREGNANT. NO ADVERSE PATIENT OUTCOMES REPORTED. LIMITED INFORMATION AVAILABLE. ALTHOUGH, FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER WITH AN EMPHASIS ON STORAGE, HANDLING AND TECHNIQUE PER THE CORRESPONDING PACKAGE INSERT-NO DEVIATIONS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005737 ↗
• MalfunctionApr 28, 2020False Positive Result; False Positive Result

  (B)(6) 2020: A (B)(6) OLD FEMALE PATIENT VISITED THE CLINIC FOR ACNE TREATMENT. THE PATIENT'S URINE WAS COLLECTED AT 14:50 AND TESTED ON THE CONSULT DIAGNOSTICS HCG COMBO CASSETTE AT 15:09, WHICH PROVIDED A POSITIVE RESULT. THE PATIENTS' BLOOD WAS DRAWN FOR A CONFIRMATORY BETA HCG. CONFIRMATORY BETA HCG PROVIDED A NEGATIVE RESULT OF <2.39 MIU/ML. NO ADVERSE PATIENT OUTCOMES REPORTED. LIMITED INFORMATION AVAILABLE. ALTHOUGH, FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER WITH AN EMPHASIS ON STORAGE, HANDLING AND TECHNIQUE PER THE CORRESPONDING PACKAGE INSERT-NO DEVIATIONS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005728 ↗
• MalfunctionApr 17, 2020False Positive Result; False Positive Result

  (B)(6) 2020: A (B)(6) OLD FEMALE VISITED CLINIC FOR AN OB RELATED SURGERY. PATIENTS SERUM WAS COLLECTED AT 14:30 AND TESTED ON THE CONSULT DIAGNOSTICS HCG SERUM/URINE COMBO CASSETTE AT 16:05 AND CAME BACK POSITIVE. (B)(6) 2020: CONFIRMATORY TEST PERFORMED USING THE SAME SERUM SAMPLE COLLECTED ON (B)(6) 2020 PROVIDED A NEGATIVE RESULT OF <0.10 MIU/ML. REPEAT TESTING WAS PERFORMED 2X WITH THE SAME SERUM SAMPLE ON TESTS FROM THE SAME KIT AND PROVIDED THE EXPECTED NEGATIVE RESULT BOTH TIMES. ALTHOUGH FURTHER INFORMATION WAS REQUESTED REGARDING THE TYPE OF SURGERY, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. CUSTOMER STATES THE SURGERY WAS NOT DELAYED. NO ADVERSE OUTCOMES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975384 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT PRESENTED WITH SYMPTOMS OF PREGNANCY AT THE HEALTH CENTER. THE HCG COMBO CASSETTE WAS ADMINISTERED WITH A CONFIRMED FALSE POSITIVE RESULT, SERUM HCG SAME DAY WAS <1MIU/ML. THE PATIENT RECEIVED TWO NEGATIVE RESULTS USING AN AT HOME HCG TEST. NO PROCEDURES PERFORMED BASED ON THE QUESTIONABLE TEST RESULT & ANY ADVERSE CLINICAL OUTCOMES. TROUBLESHOOTING OCCURRED REVIEWING THE POSSIBLE CONTRIBUTIONS TO THE FALSE-POSITIVE RESULT INCLUDING STORAGE/HANDLING AND TECHNIQUE.

  Patient problems: No Information

  MAUDE report 9130552 ↗
• MalfunctionSep 25, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR AN IUD INSERTION AT THE FAMILY HEALTH CENTER. A RAPID ASSAY YIELDED A POSITIVE URINE HCG RESULT WHICH WAS QUESTIONED BY THE PATIENT WHO WAS 8 WEEKS POST-PARTUM. A SECOND URINE WAS COLLECTED WHICH WAS ALSO POSITIVE ON RAPID ASSAY. BLOODWORK WAS THEN ORDERED, SAME DAY ((B)(6)2017) WHICH RESULTED AS ZERO HCG. THE SERUM WAS NOT RUN ON THE RAPID ASSAY. NO NEGATIVE IMPACT OCCURRED DUE TO THE FALSE POSITIVE RESULT, NO ADVERSE EVENTS. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT STORAGE/HANDLING/TECHNIQUE, SOURCES OF FALSE POSITIVE RESULTS WITH FOCUS ON 3 DROPS OF SAMPLE, NOT 3-4 DROPS; AND READ TIME OF 3-4 MINUTES, NOT 5 MINUTES.

  Patient problems: No Information

  MAUDE report 9114399 ↗
• MalfunctionSep 13, 2019False Negative Result; False Negative Result

  IT WAS REPORTED THAT MULTIPLE FALSE NEGATIVE HCG RESULTS OCCURRED IN THE SAME OFFICE WHEN USING THE HCG URINE CASSETTE. ALTHOUGH REQUESTED, NO INFORMATION WAS PROVIDED ABOUT THE EVENTS, OR WHETHER TREATMENT WAS GIVEN OR WITHHELD.

  Patient problems: No Information

  MAUDE report 9050815 ↗