McKesson 5001Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 20612479202744), received between Nov 17, 2017 and May 28, 2026 — classified as 5 injuries, 160 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (114 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 165 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT FOR (B)(6) WHEN TESTING WITH THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTE. THE PATIENT WAS BEING SCREENED FOR PREGNANCY PRIOR TO THE PRESCRIPTION OF BIRTH CONTROL. QUANTITATIVE BETA HCG TESTING WAS PERFORMED WITH A RESULT OF <5 (UNITS NOT SPECIFIED). THE INSERTION OF A NEXPLANON BIRTH CONTROL IMPLANT WAS DELAYED DUE TO THE POSITIVE RESULT. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325737 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED 18MAR2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 10. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267383 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT (B)(6). SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 20279

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267382 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED 18MAR2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 15. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267381 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 13. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267379 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED 18MAR2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 14. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267377 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 3. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267365 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 1. SEE MDRS 2027969-2026-00058, 2027969-2026-00059, 2027969-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267364 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT: 0001134798 AND LOTS: 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED 18MAR2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 4. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267363 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 9. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267362 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 7. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267361 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED 18MAR2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 6. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267360 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED (B)(6) 2026. EACH PATIENT PROVIDED URINE AND 2 OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 5. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267359 ↗
• MalfunctionMay 24, 2026False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 15-20 FALSE POSITIVE HCG RESULTS OVER THE PAST 6 WEEKS FOR 10-15 PATIENTS WHILE USING THE MCKESSON CONSULT® HCG URINE TEST CASSETTES. THE CUSTOMER REPORTED SEVERAL FALSE POSITIVES WERE OBSERVED ON LOT 0001134798 AND LOTS 0001176452 AND 0001140630 YIELDED A FEW FALSE POSITIVES. THE CUSTOMER REPORTED THE FIRST EVENT OCCURRED 18MAR2026. EACH PATIENT PROVIDED URINE AND 2OZ OF URINE WAS APPLIED TO EACH TEST. DUE TO THE VOLUME OF SAMPLE BEING INDICATED, ATTEMPTS WERE MADE TO CLARIFY THIS INFORMATION HOWEVER, THEY WERE UNSUCCESSFUL. THE RESULTS WERE READ AT 1 TO 2 MINUTES AND A FALSE POSITIVE RESULT WAS OBTAINED. IN SOME INSTANCES, REPEAT TESTING YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. IT IS CURRENTLY UNCLEAR IF EVERY PATIENT HAD CONFIRMATORY TESTING PERFORMED. THE CUSTOMER INDICATED BOTH 10 PATIENTS WERE "IMPACTED" AND "NO PATIENT IMPACT". NO SPECIFIC ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE, THIS REPORT IS FOR PATIENT 8. SEE MDRS 2027969-2026-00057, 2027969-2026-00058, 2027969-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267357 ↗
• MalfunctionMay 22, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT WITH THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTE. THE PATIENT WAS BEING SEEN FOR A BIRTH CONTROL CONSULTATION. THE PATIENT HAD AN IUD THAT WAS PLACED ON (B)(6) 2025. THE PATIENT DECIDED TO HAVE THE IUD REMOVED BASED ON THE POSITIVE RESULT, HOWEVER THE PROVIDER WAS UNABLE TO REMOVE THE IUD AS THE STRINGS WERE NOT VISIBLE. QUALITATIVE SERUM HCG TESTING WAS PERFORMED (METHOD NOT SPECIFIED) AND THE RESULT WAS NEGATIVE. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260387 ↗
• MalfunctionMay 22, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT WITH THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTE. THE PATIENT WAS BEING SEEN FOR A BIRTH CONTROL CONSULTATION. QUALITATIVE SERUM HCG TESTING WAS PERFORMED (METHOD NOT SPECIFIED) AND THE RESULT WAS NEGATIVE. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260379 ↗
• MalfunctionApr 9, 2026False Positive Result

  THE DISTRIBUTOR REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS ON FIVE BOXES OF MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTE. THE NUMBER OF PATIENTS INVOLVED IS NOT KNOWN. THREE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION, HOWEVER THE CUSTOMER HAS BEEN UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837523 ↗
• MalfunctionFeb 24, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING FOUR FALSE POSITIVE HCG RESULTS WHILE USING MCKESSON CONSULT® DIAGNOSTICS HCG URINE TESTS CASSETTES ON FOUR PATIENTS. THE FOURTH PATIENT PRESENTED FOR TESTING PRIOR TO UNDERGOING AN UNSPECIFIED PROCEDURE. THE PATIENT'S URINE WAS COLLECTED, TESTED, AND A POSITIVE HCG RESULT WAS OBTAINED AT 5 MINUTES. CONFIRMATORY SERUM BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. AS A RESULT OF THE POSITIVE HCG RESULT, THE PROCEDURE WAS DELAYED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDRS 2027969-2026-00026, 2027969-2026-00027, AND 2027969-2026-00028 FOR PATIENTS 1-3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433876 ↗
• MalfunctionFeb 24, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING FOUR FALSE POSITIVE HCG RESULTS WHILE USING MCKESSON CONSULT® DIAGNOSTICS HCG URINE TESTS CASSETTES ON FOUR PATIENTS. THE THIRD PATIENT PRESENTED FOR TESTING PRIOR TO UNDERGOING A CERVICAL CANCER SCREENING PROCEDURE. THE PATIENT'S URINE WAS COLLECTED, TESTED AND THE RESULTS WERE READ AT 5 MINUTES AND A POSITIVE HCG WAS OBTAINED. CONFIRMATORY SERUM BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. AS A RESULT OF THE POSITIVE HCG RESULT, THE PROCEDURE WAS DELAYED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDRS ., 2027969-2026-00027, AND 2027969-2026-00029 FOR PATIENTS 1-2, AND 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433678 ↗
• MalfunctionFeb 24, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING FOUR FALSE POSITIVE HCG RESULTS WHILE USING MCKESSON CONSULT® DIAGNOSTICS HCG URINE TESTS CASSETTES ON FOUR PATIENTS. THE SECOND PATIENT PRESENTED FOR TESTING PRIOR TO UNDERGOING A POSTPARTUM EXAM. THE PATIENT'S URINE WAS COLLECTED, TESTED AND THE RESULTS WERE READ AT 5 MINUTES AND A POSITIVE HCG WAS OBTAINED. CONFIRMATORY SERUM BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. AS A RESULT OF THE POSITIVE HCG RESULT, THE PROCEDURE WAS DELAYED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDRS 2027969-2026-00026, 2027969-2026-00028, AND 2027969-2026-00029 FOR PATIENTS 1, 3-4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433575 ↗
• MalfunctionFeb 24, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING FOUR FALSE POSITIVE HCG RESULTS WHILE USING MCKESSON CONSULT® DIAGNOSTICS HCG URINE TESTS CASSETTES ON FOUR PATIENTS. THE FIRST PATIENT PRESENTED FOR TESTING PRIOR TO UNDERGOING ENDOMETRIAL BIOPSY AND/OR COLPOSCOPY PROCEDURE. THE PATIENT'S URINE WAS COLLECTED WHICH APPEARED CLOUDY AND RED DUE TO BLOOD. IT WAS NOT GROSSLY HEMATURIC, NO CLOTS OR VISIBLE FLOATERS. THE SAMPLE WAS TESTED, THE RESULTS WERE READ AT 3 MINUTES, AND A NEGATIVE RESULT WAS OBTAINED. THE SAME TEST WAS READ AT 5 MINUTES AND A FAINT POSITIVE HCG WAS OBTAINED. CONFIRMATORY SERUM BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. AS A RESULT OF THE POSITIVE HCG RESULT, THE PROCEDURE WAS DELAYED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDRS 2027969-2026-00027, 2027969-2026-00028, AND 2027969-2026-00029 FOR PATIENTS 2-4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433404 ↗
• MalfunctionJan 12, 2026False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING WITH THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTES WITH THREE PATIENTS. CONFIRMATORY TESTING WAS PERFORMED WITH A RESULT OF LESS THAN 5. THE CUSTOMER REPORTED THERE WAS NEGATIVE IMPACT TO THE PATIENTS AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. MDR (B)(4) FOR PATIENTS 1 AND 2 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044415 ↗
• MalfunctionJan 12, 2026False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING WITH THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTES WITH THREE PATIENTS. CONFIRMATORY TESTING WAS PERFORMED WITH A RESULT OF LESS THAN 5. THE CUSTOMER REPORTED THERE WAS NEGATIVE IMPACT TO THE PATIENTS AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. MDR (B)(4) FOR PATIENTS 1 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043915 ↗
• MalfunctionJan 12, 2026False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING WITH THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTES WITH THREE PATIENTS. CONFIRMATORY TESTING WAS PERFORMED WITH A RESULT OF LESS THAN 5. THE CUSTOMER REPORTED THERE WAS NEGATIVE IMPACT TO THE PATIENTS AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. MDR2027969-2026-00005 AND 2027969-2026-00006 FOR PATIENTS 2 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043473 ↗
• MalfunctionSep 9, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN USING THE MCKESSON CONSULT DIAGNOSTICS HCG URINE CASSETTE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THREE ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011555 ↗