McKesson 5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 20612479202751), received between Jun 19, 2017 and Mar 10, 2025 — classified as 2 injuries, 88 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (69 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-3273-2026 · 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FAINT FALSE POSITIVE HCG RESULT WHILE USING THE CONSULT HCG DIPSTICK TEST ON A NON-PREGNANT PATIENT. SPECIFICS WERE NOT PROVIDED AS TO WHY THE PATIENT PRESENTED, HOWEVER THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED USING THE CONSULT HCG DIPSTICK. THE RESULTS WERE READ AT 3 MINUTES AND A FAINT FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A CONSULT HCG URINE CASSETTE WHICH YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21568394 ↗
• MalfunctionMar 5, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS FOR 2 DIFFERENT INDIVIDUALS WHEN USING CONSULT HCG DIPSTICK TESTS AND CONSULT HCG URINE CASSETTES. THE CUSTOMER REPORTED AFTER RECEIVING DISCREPANT RESULTS FOR THE FIRST PATIENT, THE CUSTOMER DECIDED TO TEST A COLLEAGUE. THE CUSTOMER'S COLLEAGUE PROVIDED A FRESH URINE SAMPLE WHICH YIELDED A FAINT POSITIVE HCG RESULT WITH THE DIPSTICK TEST AND A NEGATIVE HCG RESULT FOR THE CASSETTE TEST. THE CUSTOMER INDICATED THEY CONSIDERED THE FAINT POSITIVE HCG RESULT TO BE FALSE FOR THE COLLEAGUE. NO ADVERSE EVENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2025-00057 FOR THE DISCREPANT RESULT ON PATIENT 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527958 ↗
• MalfunctionFeb 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING TWO FALSE POSITIVE HCG RESULTS WHILE USING CONSULT HCG DIPSTICK TESTS ON TWO PATIENTS. THE FIRST PATIENT PRESENTED FOR PREGNANCY TESTING PRIOR TO UNDERGOING AN ENDOMETRIAL BIOPSY AND SURGERY DUE TO PAIN. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH YIELDED A POSITIVE HCG RESULT. A CONFIRMATORY BLOOD TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. HOWEVER, AS A RESULT OF THE POSITIVE HCG RESULT, THE ENDOMETRIAL BIOPSY PROCEDURE WAS RESCHEDULED FOR (B)(6) 2025. ALTHOUGH THE CUSTOMER REPORTED A DELAY IN UNDERGOING THE ENDOMETRIAL BIOPSY PROCEDURE, THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS THE SURGERY WAS SCHEDULED FOR (B)(6) 2025 DUE TO OR AVAILABILITY. THE CUSTOMER MENTIONED THE PATIENT EXPRESSED FRUSTRATION DUE TO THE PAIN THEY WERE IN, HOWEVER THE FALSE POSITIVE HCG RESULT DID NOT RESULT IN A DELAY IN TREATMENT. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00052 REGARDING THE FALSE POSITIVE EVENT ON THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438768 ↗
• MalfunctionFeb 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING TWO FALSE POSITIVE HCG RESULTS WHILE USING CONSULT HCG DIPSTICK TESTS ON TWO PATIENTS. THE SECOND PATIENT PRESENTED FOR AN UNSPECIFIED REASON. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH YIELDED A POSITIVE HCG RESULT. A SECOND TEST WAS PERFORMED USING THE SAME URINE SAMPLE WITH A CONSULT HCG DEVICE FROM A DIFFERENT KIT (SAME LOT) WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED. SEE MDR 2027969-2025-00051 REGARDING THE FALSE POSITIVE EVENT ON THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437973 ↗
• MalfunctionFeb 18, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING THE CONSULT HCG DIPSTICK TEST ON A PATIENT. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH HAD NO APPEARANCE ISSUES. THE SAMPLE WAS TESTED, THE RESULTS WERE READ BETWEEN 3-4 MINUTES, AND A FALSE POSITIVE HCG RESULT WAS OBSERVED. THE CUSTOMER REPORTED RETESTING WAS PERFORMED USING A DEVICE FROM THE SAME LOT NUMBER AND A NEGATIVE HCG RESULT WAS OBTAINED. ADDITIONALLY, A CONFIRMATORY BLOOD TEST WAS PERFORMED WHICH ALSO YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398123 ↗
• MalfunctionJan 20, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING TWO PATIENTS WITH THE CONSULT DIAGNOSTICS HCG URINE TESTS DIPSTICK. THE CUSTOMER WAS UNABLE TO PROVIDE ANY INFORMATION ON THE SECOND PATIENT, AS THE EVENT HAD OCCURRED SOME TIME AGO. NO ADVERSE EVENTS WERE REPORTED. SEE H10 FOR MDR NUMBER RELATED TO THE OTHER PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194240 ↗
• MalfunctionJan 20, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING TWO PATIENTS WITH THE CONSULT DIAGNOSTICS HCG URINE TESTS DIPSTICK. PATIENT (B)(6) WAS TESTED TWICE, BOTH TIMES WITH POSITIVE RESULTS. THE PATIENT'S PRESCRIPTION WAS CHANGED FROM SUBOXONE (BUPRENORPHINE/NALOXONE) TO BUPRENORPHINE DUE TO THE FALSE POSITIVE RESULTS. THE PATIENT STATED THAT IT WAS IMPOSSIBLE THAT SHE WAS PREGNANT AND PERFORMED HER OWN PREGNANCY TEST THE FOLLOWING DAY WITH A NEGATIVE RESULT. THE PATIENT HAD NOT TAKEN ANY OF THE NEW MEDICATION, AND THE PRESCRIPTION WAS CHANGED BACK FOLLOWING THE NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT THERE WAS NO NEGATIVE IMPACT DUE TO THE CHANGE IN MEDICATION. SEE H10 FOR MDR NUMBER RELATED TO THE OTHER PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194231 ↗
• MalfunctionJan 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING SEVERAL FALSE POSITIVE RESULTS WHILE USING THE CONSULT HCG URINE TESTS ON FOUR DIFFERENT PATIENTS. ON (B)(6) 2024, THE CUSTOMER INDICATED ONE PATIENT RECEIVED FALSE POSITIVE HCG RESULTS ON THAT DAY AND THREE PATIENTS RECEIVED FALSE POSITIVE RESULTS ONE MONTH PRIOR. IT WAS REPORTED THAT ALL PATIENTS HAD CONFIRMATORY TESTING PERFORMED WHICH YIELDED NEGATIVE HCG RESULTS. THE CUSTOMER INDICATED THE MOST RECENT PATIENT FROM (B)(6) 2024 PROVIDED A FRESH URINE SAMPLE, THE RESULTS WERE READ AT 5 MINUTES AND 3 POSITIVE HCG RESULTS WERE OBSERVED. TECHNICAL SERVICES ADVISED PER THE PACKAGE INSERT, READ THE RESULT AT 3-4 MINUTES. DO NOT INTERPRET RESULTS AFTER THE APPROPRIATE READ TIME. NO ADVERSE EVENTS WERE REPORTED, THEREFORE THIS EVENT IS NOT CONSIDERED REPORTABLE. IT IS CURRENTLY UNCLEAR IF THIS READ TIME DEVIATION APPLIES TO THE 3 PATIENTS FROM THE MONTH PRIOR, THEREFORE 3 MDRS WILL BE CONSERVATIVELY FILED. SEE MDR 2027969-2025-00008 AND 2027969-2025-00009 REGARDING THE FALSE POSITIVE RESULTS FROM PATIENT 1 AND 2 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107791 ↗
• MalfunctionJan 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING SEVERAL FALSE POSITIVE RESULTS WHILE USING THE CONSULT HCG URINE TESTS ON FOUR DIFFERENT PATIENTS. ON (B)(6) 2024, THE CUSTOMER INDICATED ONE PATIENT RECEIVED FALSE POSITIVE HCG RESULTS ON THAT DAY AND THREE PATIENTS RECEIVED FALSE POSITIVE RESULTS ONE MONTH PRIOR. IT WAS REPORTED THAT ALL PATIENTS HAD CONFIRMATORY TESTING PERFORMED WHICH YIELDED NEGATIVE HCG RESULTS. THE CUSTOMER INDICATED THE MOST RECENT PATIENT FROM (B)(6) 2024 PROVIDED A FRESH URINE SAMPLE, THE RESULTS WERE READ AT 5 MINUTES AND 3 POSITIVE HCG RESULTS WERE OBSERVED. TECHNICAL SERVICES ADVISED PER THE PACKAGE INSERT, READ THE RESULT AT 3-4 MINUTES. DO NOT INTERPRET RESULTS AFTER THE APPROPRIATE READ TIME. NO ADVERSE EVENTS WERE REPORTED, THEREFORE THIS EVENT IS NOT CONSIDERED REPORTABLE. IT IS CURRENTLY UNCLEAR IF THIS READ TIME DEVIATION APPLIES TO THE 3 PATIENTS FROM THE MONTH PRIOR, THEREFORE 3 MDRS WILL BE CONSERVATIVELY FILED. SEE MDR 2027969-2025-00008 AND 2027969-2025-00010 REGARDING THE FALSE POSITIVE RESULTS FROM PATIENT 1 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107675 ↗
• MalfunctionJan 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING SEVERAL FALSE POSITIVE RESULTS WHILE USING THE CONSULT HCG URINE TESTS ON FOUR DIFFERENT PATIENTS. ON (B)(6) 2024, THE CUSTOMER INDICATED ONE PATIENT RECEIVED FALSE POSITIVE HCG RESULTS ON THAT DAY AND THREE PATIENTS RECEIVED FALSE POSITIVE RESULTS ONE MONTH PRIOR. IT WAS REPORTED THAT ALL PATIENTS HAD CONFIRMATORY TESTING PERFORMED WHICH YIELDED NEGATIVE HCG RESULTS. THE CUSTOMER INDICATED THE MOST RECENT PATIENT FROM (B)(6) 2024 PROVIDED A FRESH URINE SAMPLE, THE RESULTS WERE READ AT 5 MINUTES AND 3 POSITIVE HCG RESULTS WERE OBSERVED. TECHNICAL SERVICES ADVISED PER THE PACKAGE INSERT, READ THE RESULT AT 3-4 MINUTES. DO NOT INTERPRET RESULTS AFTER THE APPROPRIATE READ TIME. NO ADVERSE EVENTS WERE REPORTED, THEREFORE THIS EVENT IS NOT CONSIDERED REPORTABLE. IT IS CURRENTLY UNCLEAR IF THIS READ TIME DEVIATION APPLIES TO THE 3 PATIENTS FROM THE MONTH PRIOR, THEREFORE 3 MDRS WILL BE CONSERVATIVELY FILED. SEE MDR 2027969-2025-00009 AND 2027969-2025-00010 REGARDING THE FALSE POSITIVE RESULTS FROM PATIENT 2 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107398 ↗
• MalfunctionNov 13, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE PATIENT HAD EXPERIENCED A MISCARRIAGE APPROXIMATELY 6 WEEKS PRIOR. LAB TESTING WAS PERFORMED WITH A RESULT OF <5 MIU/ML. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR THREE OTHER PATIENTS. SEE H10 FOR THE RELATED REPORT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677821 ↗
• MalfunctionNov 13, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE PATIENT WAS 6 WEEKS POSTPARTUM, AND WAS BEING TESTED AS PART OF A ROUTINE FOLLOW-UP. LAB TESTING WAS PERFORMED TWICE WITH A RESULT OF <1 MIU/ML EACH TIME. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR THREE OTHER PATIENTS. SEE H10 FOR THE RELATED REPORT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676563 ↗
• MalfunctionNov 13, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE PATIENT WAS PERI-MENOPAUSAL, AND WAS BEING TESTED AS PART OF AN ANNUAL APPOINTMENT. LAB TESTING WAS PERFORMED WITH A RESULT OF 5 MIU/ML. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR THREE OTHER PATIENTS. SEE H10 FOR THE RELATED REPORT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676297 ↗
• MalfunctionNov 13, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FAINT FALSE POSITIVE RESULTS WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE SAMPLE WAS TESTED A THIRD TIME WITH A NEGATIVE RESULT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT'S CARE AS A RESULT OF THE TWO ALLEGED FALSE POSITIVES. THE CUSTOMER WAS UNABLE TO PROVIDE ANY OTHER INFORMATION REGARDING THIS EVENT. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR THREE OTHER PATIENTS. SEE H10 FOR THE RELATED REPORT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676077 ↗
• MalfunctionOct 22, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE RESULTS WHILE USING CONSULT HCG DIPSTICK TESTS ON 3 PATIENTS. THE CUSTOMER REPORTED THE THIRD PATIENT PRESENTED FOR A L-SPINE X-RAY PROCEDURE DUE TO BACK PAIN. THE PATIENT PROVIDED A FRESH URINE SAMPLE THAT WAS DIPPED FOR 5 SECONDS. THE RESULTS WERE READ AT 3 MINUTES AND A FALSE POSITIVE HCG RESULT WAS OBSERVED. AS A RESULT OF THE POSITIVE HCG RESULT, THE PROCEDURE WAS NOT PERFORMED, AND THE PATIENT WAS PROVIDED "SUPPORTIVE OVER-THE-COUNTER MEDICINES (TYLENOL EVERY 4-6 HOURS/IBUPROFEN EVERY 6-8 HOURS)" FOR THE BACK PAIN. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. SEE MDR 2027969-2024-00177 AND 2027969-2024-00178 FOR THE FIRST AND SECOND PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510408 ↗
• MalfunctionOct 22, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE RESULTS WHILE USING CONSULT HCG DIPSTICK TESTS ON 3 PATIENTS. THE CUSTOMER REPORTED THE SECOND PATIENT HAD A PREGNANCY TEST CONDUCTED AS SHE COULD NOT RECALL HER LAST MENSTRUATION. THE PATIENT PROVIDED A FRESH URINE SAMPLE THAT WAS DIPPED FOR 5 SECONDS. THE RESULTS WERE READ AT 3 MINUTES AND A FALSE POSITIVE HCG RESULT WAS OBSERVED. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2024-00177 AND 2027969-2024-00179 FOR THE FIRST AND THIRD PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509829 ↗
• MalfunctionOct 22, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE RESULTS WHILE USING CONSULT HCG DIPSTICK TESTS ON 3 PATIENTS. THE CUSTOMER REPORTED THE FIRST PATIENT TESTED POSITIVE FOR COVID-19 AND PRIOR TO ADMINISTERING A STEROID TREATMENT (4MG DEXAMETHASONE AND 40MG DEPO-MEDROL INJECTION), A PREGNANCY TEST WAS CONDUCTED. THE PATIENT PROVIDED A FRESH URINE SAMPLE THAT WAS DIPPED FOR 5 SECONDS. THE RESULTS WERE READ AT 3 MINUTES AND A FAINT FALSE POSITIVE HCG RESULT WAS OBSERVED. AS A RESULT OF THE POSITIVE HCG RESULT, THE STEROID TREATMENT WAS NOT PROVIDED. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. SEE MDR 2027969-2024-00178 AND 2027969-2024-00179 FOR THE SECOND AND THIRD PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509213 ↗
• MalfunctionOct 15, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING PATIENTS WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL DETAILS; HOWEVER THE CUSTOMER HAS BEEN UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457610 ↗
• MalfunctionOct 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING PATIENTS WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL DETAILS, HOWEVER THE CUSTOMER HAS BEEN UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447373 ↗
• MalfunctionSep 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE PATIENT WAS BEING TESTED AS PART OF A ROUTINE MEDICAL CHECKUP PRIOR TO THE PRESCRIPTION OF BIRTH CONTROL. FOLLOWING THE POSITIVE RESULT, A URINE SAMPLE WAS TESTED AT THE LAB WITH AN HCG CASSETTE (BRAND AND LOT NUMBER UNKNOWN) WITH A NEGATIVE RESULT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT'S MEDICAL CARE. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR TWO ADDITIONAL PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161472 ↗
• MalfunctionSep 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE PATIENT WAS BEING TESTED AS PART OF A ROUTINE MEDICAL CHECKUP PRIOR TO THE PRESCRIPTION OF BIRTH CONTROL. FOLLOWING THE POSITIVE RESULT, A URINE SAMPLE WAS TESTED AT THE LAB WITH AN HCG CASSETTE (BRAND AND LOT NUMBER UNKNOWN) WITH A NEGATIVE RESULT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT'S MEDICAL CARE. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR TWO ADDITIONAL PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161372 ↗
• MalfunctionAug 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING THE CONSULT HCG DIPSTICK TEST. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20057429 ↗
• MalfunctionAug 21, 2024False Negative Result; False Negative Result

  THE DISTRIBUTOR REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE CUSTOMER STATED THAT THE RESULT WAS NOT CONSISTENT WITH THE LAB TESTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER ALSO REPORTED A FALSE POSITIVE RESULT WITH THIS KIT. SEE H10 FOR THE RELATED MDR NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014034 ↗
• MalfunctionAug 18, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. THE CUSTOMER STATED THAT THE RESULT WAS NOT CONSISTENT WITH THE LAB TESTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER ALSO REPORTED A FALSE NEGATIVE RESULT WITH THIS KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19998904 ↗
• MalfunctionAug 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK. APPROXIMATELY ONE WEEK PRIOR, THE PATIENT PRESENTED WITH A HEAVY MENSTRUAL PERIOD AND AN ULTRASOUND WAS PERFORMED TO RULE OUT A MISCARRIAGE. THE ULTRASOUND INDICATED THAT THE PATIENT WAS NOT PREGNANT, HOWEVER THE PATIENT REQUESTED ADDITIONAL CONFIRMATION. TESTING WAS PERFORMED WITH THE MCKESSON CONSULT DIAGNOSTICS HCG DIPSTICK AND A FAINT POSITIVE RESULT WAS OBSERVED. THE PATIENT RETURNED TO THE HOSPITAL APPROXIMATELY ONE WEEK LATER, AND URINE AND BLOOD TESTS WERE PERFORMED WITH NEGATIVE RESULTS; THE PATIENT WAS DETERMINED NOT TO BE PREGNANT. THE PATIENT WAS A MINOR, AND WAS EMOTIONALLY DISTRESSED AT THE POSITIVE RESULT. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER ALSO REPORTED A FALSE POSITIVE RESULT FOR AN ADDITIONAL PATIENT; SEE H10 FOR THE RELATED REPORT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925118 ↗