Henry Schein 9004073Recalls & reported problems
Henry Schein, Inc. · One Step hCG Urine Cass Test · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Henry Schein One Step hCG urine cassette is a home pregnancy test. Most of the 59 reports describe results that read wrong —34 false positives and 23 false negatives — with 6 injuries and no deaths. One recall, opened in August 2026, says the tests can pick up very low hCG levels and give a false positive. Reports rose sharply, from 1 in the prior12 months to 9 in the last12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10304040024109), received between Jul 26, 2017 and Sep 22, 2026 — classified as 6 injuries, 55 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (35 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 16, 2026.
Reports received per month
Recalls naming this device
- 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-3274-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result35
- False Negative Result23
- Incorrect, Inadequate or Imprecise Result or Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient19
- Insufficient Information12
- No Known Impact Or Consequence To Patient6
- Syncope/Fainting2
- Menstrual Irregularities1
- Miscarriage1
- No Code Available1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 59.00 mg/dL compared to readings of 185.00 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 5 days. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856157 ↗MalfunctionSep 22, 2026False Positive Result
The distributor reported that a customer received a false positive hCG result while testing a patient using the HENRY SCHEIN® One Step+hCG Urine Cassette Test. The customer reported the patient presented with bleeding and pelvic pain. A Henry Schein One Step Urine hCG test was performed and a positive hCG result was obtained. As a result of the positive result and the patient's symptoms, the patient was sent to the ER, where a confirmatory blood test yielded a negative result. No adverse health outcomes were reported as a result of the false positive hCG result.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856155 ↗MalfunctionMar 23, 2026False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH THE HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST. THE CUSTOMER STATED THAT THE PATIENT WAS MORE THAN FIVE MONTHS PREGNANT. A TEST LINE EVENTUALLY APPEARED, BUT ONLY AFTER 10 MINUTES. THE TEST WAS REPEATED WITH THE SAME RESULT. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24667383 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248999 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248947 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248946 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS; HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248922 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS; HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248920 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248831 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248817 ↗MalfunctionFeb 3, 2026False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS FOR 6¿8 PATIENTS WHEN TESTING WITH THE ONE STEP+ HCG URINE CASSETTE TEST. UNSPECIFIED ADDITIONAL TESTING DETERMINED THAT THE PATIENTS WERE NOT PREGNANT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248764 ↗MalfunctionNov 6, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING SEVERAL FALSE POSITIVE RESULTS WHILE USING THE ONE STEP HCG URINE CASSETTE TESTS. THE NUMBER OF FALSE POSITIVE RESULTS OR PATIENTS INVOLVED WAS NOT PROVIDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20622910 ↗InjuryApr 19, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED RECEIVING TWO FALSE NEGATIVE HCG RESULTS FOR ONE PATIENT. THE CUSTOMER INDICATED THE PATIENT FIRST PRESENTED ON (B)(6) 2024 FOR AN EPIDURAL STEROID INJECTION DUE TO NECK PAIN. PRIOR TO THE PROCEDURE, A HENRY SCHEIN HCG COMBO DEVICE WAS SELECTED AND USED TO TEST FOR PREGNANCY. THE CUSTOMER INDICATED A NEGATIVE HCG RESULT WAS OBTAINED AND THE PATIENT WAS ADMINISTERED THE EPIDURAL STEROID INJECTION. THE PATIENT THEN PRESENTED ON (B)(6) 2024 FOR AN ADDITIONAL EPIDURAL STEROID INJECTION. PRIOR TO THE PROCEDURE, A HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST WAS SELECTED AND USED TO TEST FOR PREGNANCY. THE CUSTOMER INDICATED A NEGATIVE HCG RESULT WAS OBTAINED AND THE PATIENT WAS ADMINISTERED THE EPIDURAL STEROID INJECTION. NO ADVERSE EVENTS WERE REPORTED. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER FAINTING. THE CAUSE OF THE FAINTING WAS NOT REPORTED, HOWEVER A PREGNANCY TEST WAS PERFORMED AT THE FACILITY WHICH NOTED THE PATIENT WAS 5 WEEKS PREGNANT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 3006984151-2024-00005-00 FOR THE EVENT WHICH TOOK PLACE ON (B)(6) 2024.
Patient problems: Syncope/Fainting
MAUDE report 19142208 ↗InjuryApr 4, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED RECEIVING TWO FALSE NEGATIVE HCG RESULTS FOR ONE PATIENT. THE CUSTOMER INDICATED THE PATIENT FIRST PRESENTED ON (B)(6) 2024 FOR AN EPIDURAL STEROID INJECTION DUE TO NECK PAIN. PRIOR TO THE PROCEDURE, A HENRY SCHEIN ONE STEP+ HCG COMBO TEST WAS SELECTED AND USED TO TEST FOR PREGNANCY. THE CUSTOMER INDICATED A NEGATIVE HCG RESULT WAS OBTAINED AND THE PATIENT WAS ADMINISTERED THE EPIDURAL STEROID INJECTION. THE PATIENT THEN PRESENTED ON (B)(6) 2024 FOR AN ADDITIONAL EPIDURAL STEROID INJECTION. PRIOR TO THE PROCEDURE, A HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST WAS SELECTED AND USED TO TEST FOR PREGNANCY. THE CUSTOMER INDICATED A NEGATIVE HCG RESULT WAS OBTAINED AND THE PATIENT WAS ADMINISTERED THE EPIDURAL STEROID INJECTION. NO ADVERSE EVENTS WERE REPORTED, HOWEVER THE PATIENT DID RECEIVE TWO STEROID INJECTIONS FOR PAIN MANAGEMENT AFTER RECEIVING NEGATIVE HCG RESULTS. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER FAINTING. THE CAUSE OF THE FAINTING WAS NOT REPORTED, HOWEVER A PREGNANCY TEST WAS PERFORMED AT THE FACILITY WHICH NOTED THE PATIENT WAS 5 WEEKS PREGNANT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 2027969-2
Patient problems: Syncope/Fainting
MAUDE report 19047932 ↗MalfunctionJul 5, 2023False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN USING THE ONE STEP+ HCG URINE CASSETTE TEST. THE DISTRIBUTOR DID NOT CLARIFY WHETHER THE SAMPLES BEING TESTED WERE PATIENT SAMPLES OR CONTROLS. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION AND ADDITIONAL INFORMATION, HOWEVER THE CUSTOMER HAS BEEN UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17263509 ↗MalfunctionJul 5, 2023False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED FALSE POSITIVE RESULTS WHEN USING THE ONE STEP+ HCG URINE CASSETTE TEST. THE DISTRIBUTOR DID NOT CLARIFY WHETHER THE SAMPLES BEING TESTED WERE PATIENT SAMPLES OR CONTROLS. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION AND ADDITIONAL INFORMATION, HOWEVER THE CUSTOMER HAS BEEN UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17262842 ↗MalfunctionJun 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE DISTRIBUTOR REPORTED THAT THE ONE STEP+ HCG URINE CASSETTE TEST IS NOT GIVING ACCURATE RESULTS, AND IS TAKING TOO LONG. THE CUSTOMER DID NOT SPECIFY WHETHER THE REPORTED INACCURATE RESULTS OCCURRED ON PATIENT OR CONTROL SAMPLES, AND DID NOT ELABORATE ON THE ALLEGATION THAT THE TEST IS TAKING TOO LONG. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION, HOWEVER THE CUSTOMER HAD BEEN UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17044446 ↗MalfunctionAug 15, 2022False Positive Result; False Positive Result
ON (B)(6) 2022, A PATIENT WAS ADMINISTERED THE HENRY SCHEIN HCG URINE CASSETTE TEST FOR PREGNANCY VERIFICATION AND HAD A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF AN ADVERSE EVENT. RELATED MDRS: SEE MDR 2027969-2022-00065 AND 2027969-2022-00066.
Patient problems: Insufficient Information
MAUDE report 15224732 ↗MalfunctionAug 15, 2022False Positive Result; False Positive Result
ON (B)(6) 2022, A PATIENT WAS ADMINISTERED THE HENRY SCHEIN HCG URINE CASSETTE TEST FOR PREGNANCY VERIFICATION AND HAD A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF AN ADVERSE EVENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN PROVIDED. RELATED MDRS: SEE MDR 2027969-2022-00065 AND 2027969-2022-00064.
Patient problems: Insufficient Information
MAUDE report 15224725 ↗MalfunctionAug 15, 2022False Positive Result; False Positive Result
ON (B)(6) 2022, A PATIENT WAS ADMINISTERED THE HENRY SCHEIN HCG URINE CASSETTE TEST FOR PREGNANCY VERIFICATION AND HAD A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF AN ADVERSE EVENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN PROVIDED. RELATED MDRS: SEE MDR 2027969-2022-00064 AND 2027969-2022-00066.
Patient problems: Insufficient Information
MAUDE report 15224724 ↗MalfunctionJun 21, 2022False Positive Result; False Positive Result
(B)(6) 2022: FALSE POSITIVE RESULT ON THE HENRY SCHEIN HCG URINE CASSETTE. NO ADVERSE OUTCOMES REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14760548 ↗MalfunctionJun 21, 2022False Positive Result; False Positive Result
ON (B)(6) 2022: FALSE POSITIVE RESULT ON THE HENRY SCHEIN HCG URINE CASSETTE. NO ADVERSE OUTCOMES REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14760484 ↗MalfunctionMay 19, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED THAT ON (B)(6) 2022, A PATIENT NEEDING CONTRACEPTION MANAGEMENT HAD A FALSE POSITIVE RESULT USING THE HENRY SCHEIN HCG URINE CASSETTE. THE PATIENT WAS NOT SEXUALLY ACTIVE THEREFORE QUESTIONED THE RESULTS. ON THE SAME DAY, A DIFFERENT LOT OF THE HENRY SCHEIN HCG URINE CASSETTE WAS USED AS A COMPARISON WHICH PRODUCED A NEGATIVE RESULT. THE CUSTOMER BELIEVED THE NEGATIVE RESULT TO BE THE CORRECT OUTCOME. THERE WAS NO ADVERSE EVENTS FROM THE FALSE POSITIVE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14437311 ↗MalfunctionMay 12, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT A (B)(6) PATIENT HAD A FALSE NEGATIVE RESULT WHEN USING THE HENRY SCHEIN HCG URINE CASSETTE. AN UNKNOWN CONFIRMATORY LAB METHOD WAS PERFORMED WITH A POSITIVE RESULT, UNKNOWN QUANT. ALTHOUGH REQUESTED, NO OTHER INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF PATIENT HARM. MEDICATIONS: THYROID MEDICATION , PRENATAL VITAMIN, PROGESTERONE, AND ALBUTEROL.
Patient problems: Insufficient Information
MAUDE report 14380887 ↗MalfunctionMay 12, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT A PATIENT HAD A FALSE NEGATIVE RESULT WHEN USING THE HENRY SCHEIN HCG URINE CASSETTE. AN UNKNOWN CONFIRMATORY LAB METHOD WAS PERFORMED WITH A POSITIVE RESULT, UNKNOWN QUANT. ALTHOUGH REQUESTED, NO OTHER INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 14380800 ↗
Other Visual, pregnancy hCG, prescription use devices
- McKesson 5001Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls165 reports
- CARDINAL HEALTH B1077-23Cardinal Health 200, LLC · Visual, pregnancy hCG, prescription use1 recall149 reports
- McKesson 5000Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls90 reports
- Sure-Vue 4581405021Fisher Scientific Company L.L.C. · Visual, pregnancy hCG, prescription use1 recall83 reports
- McKesson 5002Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls33 reports
- Henry Schein 9004072Henry Schein, Inc. · Visual, pregnancy hCG, prescription use1 recall79 reports
- AlereTM 92210Alere San Diego, Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls23 reports
- MEDLINE MPH12025HCGMedline Industries, Inc. · Visual, pregnancy hCG, prescription use1 recall69 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page