Henry Schein 9004075Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10304040024123), received between Sep 27, 2018 and Feb 4, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (9 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-3272-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026False Negative Result

  ON 14-JAN-2026, THE DISTRIBUTOR REPORTED CONFLICTING RESULTS WHEN TESTING A PATIENT SAMPLE WITH THE ONE STEP+ HCG COMBO TEST. THE FIRST TEST YIELDED A NEGATIVE RESULT AT THE READ TIME OF 3 MINUTES, WITH A FAINT LINE APPEARING AFTER 15 MINUTES. THE PATIENT THEN UNDERWENT AN IUD INSERTION. A REPEAT TEST OF THE SAME SAMPLE YIELDED A CLEAR POSITIVE RESULT. A BLOOD SAMPLE WAS COLLECTED AND A QUANTITATIVE HCG TEST WAS PERFORMED WITH A RESULT OF 32,022.9 (UNITS NOT SPECIFIED). AN ULTRASOUND WAS PERFORMED AND A SINGLE LIVE UTERINE PREGNANCY WAS DETECTED WITH AN ESTIMATED GESTATIONAL AGE OF 6 WEEKS AND 3 DAYS. FOLLOWING THE ULTRASOUND, THE IUD WAS REMOVED. AN ULTRASOUND WAS PERFORMED ON (B)(6) 2026 DUE TO CRAMPING AND BLEEDING. THE ULTRASOUND SHOWED NO COMPLICATIONS; THE PREGNANCY WAS DETERMINED TO STILL BE VIABLE. NO ADVERSE OUTCOMES HAVE BEEN REPORTED AS A RESULT OF THE IUD INSERTION, HOWEVER THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY DUE TO THE POTENTIAL FOR MISCARRIAGE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Intermenstrual Bleeding

  MAUDE report 24263204 ↗
• InjuryFeb 4, 2026False Negative Result

  ON 14-JAN-2026 THE DISTRIBUTOR REPORTED CONFLICTING RESULTS WHEN TESTING A PATIENT SAMPLE WITH THE ONE STEP+ HCG COMBO TEST. THE FIRST TEST YIELDED A NEGATIVE RESULT AT THE READ TIME OF 3 MINUTES, WITH A FAINT LINE APPEARING AFTER 15 MINUTES. THE PATIENT THEN UNDERWENT AN IUD INSERTION. A REPEAT TEST OF THE SAME SAMPLE YIELDED A CLEAR POSITIVE RESULT. A BLOOD SAMPLE WAS COLLECTED AND A QUANTITATIVE HCG TEST WAS PERFORMED WITH A RESULT OF 32,022.9 (UNITS NOT SPECIFIED). AN ULTRASOUND WAS PERFORMED AND A SINGLE LIVE UTERINE PREGNANCY WAS DETECTED WITH AN ESTIMATED GESTATIONAL AGE OF 6 WEEKS AND 3 DAYS. FOLLOWING THE ULTRASOUND, THE IUD WAS REMOVED. AN ULTRASOUND WAS PERFORMED ON (B)(6) 2026 DUE TO CRAMPING AND BLEEDING. THE ULTRASOUND SHOWED NO COMPLICATIONS; THE PREGNANCY WAS DETERMINED TO STILL BE VIABLE. NO ADVERSE OUTCOMES HAVE BEEN REPORTED AS A RESULT OF THE IUD INSERTION, HOWEVER THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY DUE TO THE POTENTIAL FOR MISCARRIAGE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Intermenstrual Bleeding

  MAUDE report 24261944 ↗
• InjuryApr 22, 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 10FEB2024 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 27FEB2024 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 5MAR2024, 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-

  Patient problems: Syncope/Fainting

  MAUDE report 19154078 ↗
• 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 19047925 ↗
• InjuryFeb 10, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING WITH THE HENRY SCHEIN HCG COMBO CASSETTE (SENSITIVITY OF 25 MIU/ML). A PATIENT URINE SAMPLE WAS TESTED AS A SCREEN PRIOR TO PLACEMENT OF AN IUD CONTRACEPTIVE. THE URINE SAMPLE WAS FRESHLY VOIDED, BUT WAS NOT A FIRST MORNING SAMPLE. THE RESULT WAS READ AT THE APPROPRIATE 3-MINUTE READ TIME, AND WAS INTERPRETED AS NEGATIVE, AFTER WHICH THE IUD WAS IMPLANTED. APPROXIMATELY 15 MINUTES AFTER THE PATIENT LEFT THE OFFICE, A MEDICAL ASSISTANT NOTICED THAT THE RESULT ON THE HCG COMBO CASSETTE HAD CHANGED FROM NEGATIVE TO POSITIVE, AND THE PATIENT WAS CALLED BACK FOR CONFIRMATORY TESTING. THE QUANTITATIVE BLOOD TEST WAS POSITIVE WITH A RESULT OF 82 MIU/ML, AND THE IUD WAS SUBSEQUENTLY REMOVED. THE PATIENT EXPERIENCED A MISCARRIAGE. THE DOCTOR CONTINUED TO TRACK THE PATIENT¿S HCG LEVEL, WHICH WAS 4 MIU/ML AS OF (B)(6) 2023.

  Patient problems: Spontaneous Abortion

  MAUDE report 16358992 ↗
• MalfunctionApr 14, 2021False Negative Result; False Negative Result

  (B)(6) 2021: FALSE NEGATIVE RESULT ON THE HENRY SCHEIN HCG COMBO CASSETTE KIT. PATIENT OBTAINED A POSITIVE RESULT ON A HOME PREGNANCY TEST PRIOR TO THE DOCTOR VISIT (BRAND/SPECIFICITY NOT PROVIDED). CONFIRMATORY BLOOD TEST PROVIDED A NEGATIVE RESULT. ALTHOUGH THE RAPID TEST AND CONFIRMATORY TEST PROVIDED A NEGATIVE RESULT, PATIENT WAS ADAMANT SHE WAS PREGNANT. PHYSICIAN PERFORMED AN ENDOMETRIAL BIOPSY ON THE PATIENT DUE TO POSITIVE HOME PREGNANCY TEST. CHORIONIC VILLI WAS PRESENT AND PATIENT WAS DETERMINED TO BE PREGNANT AT THE TIME OF BIOPSY. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668596 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  (B)(6) 2018: PATIENT PRESENTED TO THE FACILITY FOR AN UNSPECIFIED REASON. THE SAME PATIENT URINE SAMPLE WAS TESTED 3X ON THREE DIFFERENT LOT NUMBERS YESTERDAY AND RECEIVED CONFLICTING RESULTS: FIRST TEST IN OB/GYN DEPARTMENT: LN HCG8050157-NEGATIVE AT 3MIN. SECOND TEST IN STAT DEPARTMENT: LN HCG8010037- POSITIVE AT 3 MIN 20 SECONDS. THIRD TEST IN CUSTOMER'S LAB: LN HCG8050175- NEGATIVE AT 3 MINUTES, POSITIVE AT 3MIN 20 SECONDS. NO CONFIRMATORY TESTING WAS PERFORMED. NO TREATMENT WAS PROVIDED OR DELAYED BASED ON THE CONFLICTING RESULTS. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION ABLE TO BE PROVIDED BY THE CUSTOMER. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT POSSIBLE CAUSES FOR UNEXPECTED RESULTS FOCUSING ON PROPER SAMPLING TECHNIQUE, STORAGE CONDITIONS AND PATIENT SPECIFIC FACTORS PER THE PACKAGE INSERT (PI)-NO DEVIATIONS NOTED. TECHNICAL SERVICES SPECIALIST INFORMED CUSTOMER PER THE PI: THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED. THE READ TIME FOR URINE SAMPLES IS 3 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131296 ↗
• MalfunctionApr 25, 2019False Negative Result; False Negative Result

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT TESTED HERSELF ON FIVE AT HOME URINE PREGNANCY TESTS AND OBTAINED POSITIVE RESULTS X5. THE TEST BRAND WAS UNKNOWN. THEN ON (B)(6) 2019, THE PATIENT PRESENTED TO THE FACILITY TO CONFIRM THE PREGNANCY. THE PATIENT'S URINE WAS TESTED ON THE HENRY SCHEIN HCG COMBO TEST AND PROVIDED A NEGATIVE RESULT. CONFIRMATORY BLOODWORK WAS THEN PERFORMED ON THE SAME DAY AND PROVIDED A SERUM BETA QUANT=212 MIU/ML. THERE WAS NO TREATMENT PROVIDED OR WITHHELD BASED ON THE NEGATIVE RAPID RESULT. NO ADVERSE PATIENT EVENT OCCURRED. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED ON POSSIBLE CAUSES OF FALSE NEGATIVE RESULTS, SUCH AS DEVIATIONS IN STORAGE, TECHNIQUE, AND HANDLING. THE CUSTOMER WAS ALSO ADVISED PER THE PI THAT THIS TEST PROVIDES ONLY A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8553352 ↗
• InjurySep 27, 2018False Negative Result; False Negative Result

  THE DISTRIBUTOR REPORTED THE EVENT ON BEHALF OF THE CUSTOMER. THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2018. ON (B)(6) 2018, THE PATIENT PRESENTED AT THE FACILITY FOR AN IUD INSERTION. A URINE SAMPLE WAS COLLECTED AND A HENRY SCHEIN HCG COMBO TEST PRODUCED A (B)(6) HCG RESULT. BASED ON THE (B)(6) HCG RESULT, THE PHYSICIAN PROCEEDED WITH THE IUD INSERTION. AT SOME POINT BETWEEN 7 AND 10 MINUTES, THE LABORATORY OBSERVED A FAINT (B)(6) LINE HAD DEVELOPED ON THE HENRY SCHEIN HCG COMBO TEST. THE PHYSICIAN ORDERED BLOOD WORK AND A SERUM BETA HCG QUANTITATIVE TEST PRODUCED A RESULT OF 49 MIU/ML. ON (B)(6) 2018, A REPEAT SERUM BETA HCG QUANTITATIVE TEST PRODUCED A RESULT OF 68 MIU/ML. ON (B)(6) 2018, THE IUD WAS REMOVED FROM THE PATIENT. ON (B)(6) 2018, A THIRD SERUM BETA HCG QUANTITATIVE TEST PRODUCED A RESULT OF 87 MIU/ML. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED PRE-NATAL CASE AND NO ADVERSE OUTCOMES WERE REPORTED. ADDITIONAL SERUM BETA HCG QUANTITATIVE TESTING WAS PERFORMED ON THE PATIENT. ON (B)(6) 2018, THE PATIENT'S HCG WAS DETERMINED TO BE 366 MIU/ML. ON (B)(6) 2018, THE PATIENT'S HCG WAS DETERMINED TO BE 3037 MIU/ML. AN ULTRASOUND WAS ALSO PERFORMED ON (B)(6) 2018 AND REVEALE

  Patient problems: No Code Available

  MAUDE report 7915577 ↗
• MalfunctionSep 27, 2018False Negative Result; False Negative Result

  THE DISTRIBUTOR REPORTED THE EVENT ON BEHALF OF THE CUSTOMER. ON (B)(6) 2018, THE PATIENT PRESENTED AT THE FACILITY TO CONFIRM A POSITIVE HOME PREGNANCY TEST. PER THE CUSTOMER, THE HOME PREGNANCY TEST RESULTED IN A "FAINT POSITIVE." A URINE SAMPLE WAS COLLECTED AND A HENRY SCHEIN HCG COMBO TEST PRODUCED A NEGATIVE HCG RESULT. THE PHYSICIAN ORDERED BLOOD WORK AND A SERUM BETA HCG QUANTITATIVE TEST PRODUCED A RESULT OF 127,613 MIU/ML. THE PATIENT WAS PROVIDED WITH PRENATAL CARE. TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER. THE CUSTOMER WAS DETERMINED TO BE USING NON-VALIDATED CONTROLS (QUANTIMETRIX).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915363 ↗