CARDINAL HEALTH B1077-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20885380020244), received between Nov 30, 2023 and Sep 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (7 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-3273-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED POSITIVE HCG RESULTS WHILE TESTING 2 LOTS OF CARDINAL HEALTH¿ HCG DIPSTICK RAPID TESTS. THE CUSTOMER REPORTED 7 FALSE POSITIVE HCG RESULTS WERE OBTAINED (3 AND 4) WHILE USING DEVICES FROM LOT NUMBERS 0000909383 AND 0000946100 RESPECTIVELY. HCG CONTROLS WERE TESTED USING BOTH LOTS PRIOR WHICH YIELDED PASSING RESULTS. THE DIPSTICKS WERE ALSO TESTED ON OTHER PATIENTS WITHOUT ISSUE. NO ADVERSE EVENT OR HEALTH OUTCOMES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE 2027969-2025-00192 FOR EVENTS ON LOT NUMBER 0000909383.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009896 ↗
• MalfunctionSep 9, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED POSITIVE HCG RESULTS WHILE TESTING 2 LOTS OF CARDINAL HEALTH¿ HCG DIPSTICK RAPID TESTS. THE CUSTOMER REPORTED 7 FALSE POSITIVE HCG RESULTS WERE OBTAINED (3 AND 4) WHILE USING DEVICES FROM LOT NUMBERS 0000909383 AND 0000946100 RESPECTIVELY. HCG CONTROLS WERE TESTED USING BOTH LOTS PRIOR WHICH YIELDED PASSING RESULTS. THE DIPSTICKS WERE ALSO TESTED ON OTHER PATIENTS WITHOUT ISSUE. NO ADVERSE EVENT OR HEALTH OUTCOMES WERE REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE 2027969-2025-00191 FOR EVENTS ON LOT NUMBER 0000946100.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009895 ↗
• MalfunctionJul 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ISSUES WHEN TESTING WITH THE CARDINAL HEALTH HCG DIPSTICK RAPID TEST. THE CUSTOMER STATED THAT THEY HAD BEEN HAVING INTERMITTENT ISSUES OVER THE PAST COUPLE MONTHS, AND THAT IN ONE RECENT INCIDENT THEY HAD TO USE 6 TESTS TO OBTAIN AN ACCURATE RESULT. THE CUSTOMER WAS UNRESPONSIVE TO THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571633 ↗
• MalfunctionJul 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ISSUES WHEN TESTING WITH THE CARDINAL HEALTH HCG DIPSTICK RAPID TEST. THE CUSTOMER STATED THAT THEY HAD BEEN HAVING INTERMITTENT ISSUES OVER THE PAST COUPLE MONTHS, AND THAT IN ONE RECENT INCIDENT THEY HAD TO USE 6 TESTS TO OBTAIN AN ACCURATE RESULT. THE CUSTOMER WAS UNRESPONSIVE TO THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571616 ↗
• MalfunctionFeb 2, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED "PREGNANCY TESTS ARE SHOWING FALSE POSITIVES" WHILE USING CARDINAL RAPID HCG DIPSTICK TESTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636943 ↗
• MalfunctionNov 30, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE TESTING WITH THE CARDINAL RAPID TEST HCG DIPSTICKS. THE CUSTOMER REPORTED A PATIENT WAS TESTED WHICH YIELDED A POSITIVE RESULT. A FOLLOW UP QUANTITATIVE SERUM TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. AS A RESULT, SEVERAL EMPLOYEES WERE THEN TESTED AND 3 OUT OF 5 DEVICES YIELDED POSITIVE RESULTS AND THE CUSTOMER REPORTS NONE ARE PREGNANT. NO INFORMATION WAS PROVIDED REGARDING SAMPLE COLLECTION, APPEARANCE OR TESTING TECHNIQUE. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00111 FOR FALSE POSITIVE RESULTS OBTAINED ON PATIENT. SEE MDRS 2027969-2023-00112 AND 2027969-2023-00113 FOR FALSE POSITIVE RESULTS OBTAINED ON EMPLOYEES 1 AND 2 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241724 ↗
• MalfunctionNov 30, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE TESTING WITH THE CARDINAL RAPID TEST HCG DIPSTICKS. THE CUSTOMER REPORTED A PATIENT WAS TESTED WHICH YIELDED A POSITIVE RESULT. A FOLLOW UP QUANTITATIVE SERUM TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. AS A RESULT, SEVERAL EMPLOYEES WERE THEN TESTED AND 3 OUT OF 5 DEVICES YIELDED POSITIVE RESULTS AND THE CUSTOMER REPORTS NONE ARE PREGNANT. NO INFORMATION WAS PROVIDED REGARDING SAMPLE COLLECTION, APPEARANCE OR TESTING TECHNIQUE. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00112, 2027969-2023-00113, 2027969-2023-00114 FOR THE THREE FALSE POSITIVE RESULTS OBTAINED ON EMPLOYEES 1,2 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241321 ↗
• MalfunctionNov 30, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE TESTING WITH THE CARDINAL RAPID TEST HCG DIPSTICKS. THE CUSTOMER REPORTED A PATIENT WAS TESTED WHICH YIELDED A POSITIVE RESULT. A FOLLOW UP QUANTITATIVE SERUM TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. AS A RESULT, SEVERAL EMPLOYEES WERE THEN TESTED AND 3 OUT OF 5 DEVICES YIELDED POSITIVE RESULTS AND THE CUSTOMER REPORTS NONE ARE PREGNANT. NO INFORMATION WAS PROVIDED REGARDING SAMPLE COLLECTION, APPEARANCE OR TESTING TECHNIQUE. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00111 FOR FALSE POSITIVE RESULTS OBTAINED ON PATIENT. SEE MDRS 2027969-2023-00112 AND 2027969-2023-00114 FOR FALSE POSITIVE RESULTS OBTAINED ON EMPLOYEES 1 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239754 ↗
• MalfunctionNov 30, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE TESTING WITH THE CARDINAL RAPID TEST HCG DIPSTICKS. THE CUSTOMER REPORTED A PATIENT WAS TESTED WHICH YIELDED A POSITIVE RESULT. A FOLLOW UP QUANTITATIVE SERUM TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. AS A RESULT, SEVERAL EMPLOYEES WERE THEN TESTED AND 3 OUT OF 5 DEVICES YIELDED POSITIVE RESULTS AND THE CUSTOMER REPORTS NONE ARE PREGNANT. NO INFORMATION WAS PROVIDED REGARDING SAMPLE COLLECTION, APPEARANCE OR TESTING TECHNIQUE. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00111 FOR FALSE POSITIVE RESULTS OBTAINED ON THE PATIENT. SEE MDRS 2027969-2023-00113 AND 2027969-2023-00114 FOR FALSE POSITIVE RESULTS OBTAINED ON EMPLOYEES 2 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239521 ↗