Henry Schein 9004072Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10304040024093), received between Aug 9, 2017 and Mar 6, 2026 — classified as 6 injuries, 73 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (58 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026False Negative Result

  THE DISTRIBUTOR REPORTED A FALSE NEGATIVE RESULT WHEN TESTING WITH THE HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST. THE PATIENT USED A HOME TEST AND THE RESULT WAS POSITIVE. NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537018 ↗
• MalfunctionMar 6, 2026False Negative Result

  THE DISTRIBUTOR REPORTED A FALSE NEGATIVE RESULT WHEN TESTING WITH THE HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST. THE PATIENT USED A HOME TEST AND THE RESULT WAS POSITIVE. NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536954 ↗
• MalfunctionMar 6, 2026False Negative Result

  THE DISTRIBUTOR REPORTED A FALSE NEGATIVE RESULT WHEN TESTING WITH THE HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST. THE PATIENT USED A HOME TEST AND THE RESULT WAS POSITIVE. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536762 ↗
• MalfunctionMay 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FAINT FALSE POSITIVE HCG RESULT WHILE USING THE HENRY SCHEIN HCG DIPSTICK URINE TEST. A CONFIRMATORY BLOOD TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110100 ↗
• MalfunctionApr 2, 2025False Negative Result; False Negative Result

  THE DISTRIBUTOR STATED THE CUSTOMER REPORTED "RUNNING NEGATIVE RESULTS" ON TWO LOTS OF HENRY SCHEIN HCG DIPSTICK URINE TESTS. THE CUSTOMER RETURNED 4 BOXES OF LOT 0000849001 AND 1 KIT OF LOT 0000831257 TO THE DISTRIBUTOR. IT IS UNCLEAR IF THE NEGATIVE RESULTS WERE OBTAINED WITH PATIENT SAMPLES OR CONTROLS, OR THE NUMBER OF NEGATIVE RESULTS OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED. THIS EVENT IS CONSERVATIVELY BEING REPORTED AS A REPORTABLE MALFUNCTION. SEE MDR 2027969-2025-00080 FOR THE REPORTED ISSUE ON LOT 0000849001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755687 ↗
• MalfunctionApr 2, 2025False Negative Result; False Negative Result

  THE DISTRIBUTOR STATED THE CUSTOMER REPORTED "RUNNING NEGATIVE RESULTS" ON TWO LOTS OF HENRY SCHEIN HCG DIPSTICK URINE TESTS. THE CUSTOMER RETURNED 4 BOXES OF LOT 0000849001 AND 1 KIT OF LOT 0000831257 TO THE DISTRIBUTOR. IT IS UNCLEAR IF THE NEGATIVE RESULTS WERE OBTAINED WITH PATIENT SAMPLES OR CONTROLS, OR THE NUMBER OF NEGATIVE RESULTS OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED. THIS EVENT IS CONSERVATIVELY BEING REPORTED AS A REPORTABLE MALFUNCTION. SEE MDR 2027969-2025-00081 FOR THE REPORTED ISSUE ON LOT 0000831257.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755505 ↗
• InjuryMar 24, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING FALSE NEGATIVE HCG RESULTS WITH FOUR BOXES OF HENRY SCHEIN HCG DIPSTICK URINE TESTS. TECHNICAL SERVICES ATTEMPTED TO CLARIFY THE TOTAL NUMBER OF FALSE NEGATIVE RESULTS OBTAINED AND NUMBER OF PATIENTS INVOLVED, HOWEVER, THEY WERE UNRESPONSIVE. THE CUSTOMER INDICATED ONLY 1 PATIENT WAS IMPACTED AND TESTING TOOK PLACE ON (B)(6)2025, HOWEVER LIMITED INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED THE PATIENT WAS TESTED DUE TO AMENORRHEA WITH A MIRENA IUD IMPLANTED. DURING THE TROUBLESHOOTING PROCESS, THE CUSTOMER REPORTED THE CONTROL LINE WAS NOT PRESENT AND THE BACKGROUND WAS NOT CLEAR WHEN THE RESULTS WERE INTERPRETED. ADDITIONALLY, A TIMER WAS NOT USED. ACCORDING TO THE PACKAGE INSERT, NEGATIVE: ONE RED LINE APPEARS IN THE CONTROL REGION (C). NO APPARENT RED OR PINK LINE APPEARS IN THE TEST REGION (T). INVALID: CONTROL LINE FAILS TO APPEAR. ADDITIONALLY, READ THE RESULT AT 3-4 MINUTES. DO NOT INTERPRET RESULTS AFTER THE APPROPRIATE READ TIME. IT IS IMPORTANT THAT THE BACKGROUND IS CLEAR BEFORE THE RESULT IS READ. THE CUSTOMER INDICATED CONFIRMATORY TESTING WAS PERFORMED ON (B)(6) 2025 USING A FRESH URINE SAMPLE, A DEVICE FROM A DIFFERENT LOT, AND A P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684070 ↗
• InjuryFeb 7, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING A FALSE NEGATIVE HCG RESULT WHILE USING THE HENRY SCHEIN HCG URINE DIPSTICK. THE PATIENT WAS TESTED DUE TO AMENORRHEA AND HAD BEEN TAKING A CONTINUOUS ORAL CONTRACEPTIVE PILL. THE PATIENT PROVIDED A FRESH URINE SAMPLE ON (B)(6) 2024 WHICH WAS TESTED, THE RESULTS WERE READ AT 3 MINUTES TO 3 MINUTES AND 15 SECONDS AND YIELDED A NEGATIVE HCG RESULT. CASE DETAILS INDICATE THE PATIENT ALSO HAD A BLOOD SERUM HCG TEST PERFORMED WHICH YIELDED A POSITIVE RESULT, HOWEVER THE DATE OF THE TEST WAS NOT PROVIDED. ON (B)(6) 2025 THE PATIENT HAD UNDERWENT AN ULTRASOUND WHICH NOTED THE PATIENT WAS 19 WEEKS PREGNANT. IT WAS ESTIMATED THAT AT THE TIME OF THE (B)(6) 2024 NEGATIVE RESULT, THE PATIENT WAS 9 WEEKS PREGNANT. THE PATIENT CONTINUED TO TAKE BIRTH CONTROL, THERE WERE NO INDICATIONS OF INJURY OR HARM TO THE PATIENT OR FETUS; HOWEVER, DUE TO THE POTENTIAL OF INJURY THIS WILL BE REPORTED AS A SERIOUS INJURY. ADDITIONALLY, AS A RESULT OF THE FALSE NEGATIVE RESULT, THE PATIENT EXPERIENCED A DELAY IN PRENATAL CARE.

  Patient problems: Emotional Changes; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337321 ↗
• MalfunctionOct 9, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 14 FALSE POSITIVE HCG RESULTS WHILE USING HENRY SCHEIN ONE STEP+ HCG URINE STRIP TESTS. THE CUSTOMER WAS UNABLE TO CONFIRM THE NUMBER OF PATIENTS TESTED AS SOME WERE TESTED TWICE. EACH PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING USING DIFFERENT MEDLINE KITS WERE THEN TESTED WHICH RESULTED NEGATIVE. NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED. SEE MDR 2027969-2024-00172 FOR THE EVENTS PERTAINING TO PATIENTS THAT HAD 2 FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409302 ↗
• MalfunctionOct 7, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 14 FALSE POSITIVE HCG RESULTS WHILE USING HENRY SCHEIN ONE STEP+ HCG URINE STRIP TESTS. THE CUSTOMER WAS UNABLE TO CONFIRM THE NUMBER OF PATIENTS TESTED AS SOME WERE TESTED TWICE. EACH PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT WAS RETESTED USING A DEVICE FROM THE SAME KIT WHICH ALSO YIELDED A FALSE POSITIVE HCG RESULT. CONFIRMATORY TESTING USING DIFFERENT MEDLINE KITS WERE THEN TESTED WHICH RESULTED NEGATIVE. NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED. SEE MDR 2027969-2024-00173 FOR THE EVENTS PERTAINING TO PATIENTS THAT ONLY HAD 1 FALSE POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392374 ↗
• InjurySep 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE ONE STEP+ HCG URINE STRIP TEST. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND HEMATURIA. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR ADDITIONAL WORK-UP, WHERE IT WAS DETERMINED THAT THE PATIENT WAS NOT PREGNANT. IT WAS LATER STATED THAT THE PATIENT HAD BEEN HOSPITALIZED, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. ATTEMPTS TO OBTAIN FURTHER INFORMATION ARE ONGOING. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT FOR AN ADDITIONAL PATIENT. SEE H10 FOR THE RELATED MDR NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 20219836 ↗
• InjurySep 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE ONE STEP+ HCG URINE STRIP TEST. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND HEMATURIA. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR ADDITIONAL WORK-UP, WHERE IT WAS DETERMINED THAT THE PATIENT WAS NOT PREGNANT. IT WAS LATER STATED THAT THE PATIENT HAD BEEN HOSPITALIZED, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. ATTEMPTS TO OBTAIN FURTHER INFORMATION ARE ONGOING. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT FOR AN ADDITIONAL PATIENT. SEE H10 FOR THE RELATED MDR NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 20219835 ↗
• InjurySep 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE ONE STEP+ HCG URINE STRIP TEST. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND HEMATURIA. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR ADDITIONAL WORK-UP, WHERE IT WAS DETERMINED THAT THE PATIENT WAS NOT PREGNANT. IT WAS LATER STATED THAT THE PATIENT HAD BEEN HOSPITALIZED, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. ATTEMPTS TO OBTAIN FURTHER INFORMATION ARE ONGOING. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT FOR AN ADDITIONAL PATIENT. SEE H10 FOR THE RELATED MDR NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 20164091 ↗
• InjurySep 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE ONE STEP+ HCG URINE STRIP TEST. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND HEMATURIA. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR ADDITIONAL WORK-UP, WHERE IT WAS DETERMINED THAT THE PATIENT WAS NOT PREGNANT. IT WAS LATER STATED THAT THE PATIENT HAD BEEN HOSPITALIZED, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. ATTEMPTS TO OBTAIN FURTHER INFORMATION ARE ONGOING. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT FOR AN ADDITIONAL PATIENT. SEE H10 FOR THE RELATED MDR NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 20164082 ↗
• MalfunctionSep 6, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED AN UNSPECIFIED NUMBER OF FAINT FALSE POSITIVE RESULTS WHEN TESTING PATIENT SAMPLES WITH THE ONE STEP+ HCG URINE STRIP TEST. BLOOD WORK WAS PERFORMED FOR THE PATIENTS (METHOD NOT SPECIFIED) AND THE RESULTS WERE NEGATIVE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163865 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079487 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079409 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079210 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079194 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079173 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078589 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078513 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078474 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078370 ↗
• MalfunctionAug 27, 2024False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN TESTING SAMPLES FROM 30 DIFFERENT PATIENTS USING THE ONE STEP+ HCG URINE STRIP TEST. THREE ATTEMPTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078347 ↗