Henry Schein 9004074Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10304040024116), received between Oct 31, 2018 and Jan 14, 2025 — classified as 14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-3274-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING FALSE NEGATIVE HCG RESULTS WHILE USING THE HENRY SCHEIN ONE STEP HCG URINE CASSETTES. THE CUSTOMER INDICATING CONTROL FAILURES WERE OBSERVED DURING QC TESTING, AS A RESULT, THE CUSTOMER DECIDED TO TEST THE URINE OF A KNOWN PREGNANT PATIENT AS A FURTHER CHECK FOR DEVICE PERFORMANCE. THE PATIENT URINE SAMPLE WAS TESTED, THE RESULTS WERE READ AT 3 MINUTES AND A NEGATIVE HCG RESULT WAS OBSERVED. ALTHOUGH REQUESTED, THERE IS NO INDICATION THAT THE SAMPLE TESTED WAS INTENDED FOR PATIENT TREATMENT. NO ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153120 ↗
• MalfunctionOct 20, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE TESTING AT LEAST FOUR PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTES. THE CUSTOMER PROVIDED NO PATIENT INFORMATION. HOWEVER, NEW INFORMATION RECEIVED ON 23OCT2023 NOTED THE APPEARANCE OF THE SAMPLES WERE CLEAR AND YELLOW. THE URINE SAMPLES WERE ALLOWED TO EQUILIBRATE TO ROOM TEMPERATURE PRIOR TO TESTING AND THE TESTS WERE OUT OF THE FOIL POUCH FOR A MAXIMUM OF 3 MINUTES PRIOR TO TESTING. A TIMER WAS NOT USED; HOWEVER, THE CUSTOMER INDICATED THE RESULTS WERE READ AT 3 MINUTES AND 2 OF THE TESTS YIELDED FAINT TEST LINES AND THE OTHERS YIELDED VERY BOLD TEST LINES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980934 ↗
• MalfunctionJul 6, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021:THE CUSTOMER REPORTED THAT WHEN ADMINISTERING THE HENRY SCHEIN HCG URINE CASSETTE, FALSE NEGATIVE RESULTS OCCURRED. CONFIRMATORY BLOODWORK RESULTS WERE POSITIVE. SPECIFIC METHODOLOGY AND EXACT QUANTITATIVE RESULTS WERE REQUESTED WITH OTHER EVENT INFORMATION BUT WERE NOT PROVIDED. THERE WAS NO IMPACT OR DELAY WITH PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125747 ↗
• MalfunctionJun 2, 2021False Negative Result; False Negative Result

  UNSPECIFIED DATES: CUSTOMER STATES THEY HAVE EXPERIENCED FALSE NEGATIVE RESULTS ON 6-7 FEMALE PATIENTS, AGES RANGING FROM (B)(6), WHEN USING THE SAME LOT OF THE HENRY SCHEIN HCG URINE CASSETTE KIT. PATIENT TESTS WERE PERFORMED ON DIFFERENT DAYS, BUT CUSTOMER WAS UNABLE TO PROVIDE PATIENT SPECIFIC INFORMATION. URINE SPECIMENS USED WERE NOT FIRST MORNING URINE SAMPLES. CONFIRMATORY BLOOD WORK (HCG QUANTUM TEST) WAS PERFORMED FOR EACH PATIENT AND PROVIDED POSITIVE RESULTS FOR ALL PATIENTS. EXACT RESULTS WERE NOT PROVIDED. NO ADVERSE PATIENT OUTCOMES REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. CUSTOMER WAS UNRESPONSIVE.

  Patient problems: Insufficient Information

  MAUDE report 11925868 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  IT WAS REPORTED BY THE DISTRIBUTOR THAT FALSE POSITIVES ARE OCCURRING WITH THE HCG URINE CASSETTE TESTS AT THE OBGYN FACILITY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED AND NO ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: No Information

  MAUDE report 9130547 ↗
• MalfunctionSep 26, 2019False Positive Result; False Positive Result

  IT WAS REPORTED BY THE DISTRIBUTOR THAT A FALSE POSITIVE OCCURRED WHEN ADMINISTERING THE HCG URINE CASSETTE.

  Patient problems: No Information

  MAUDE report 9121593 ↗
• MalfunctionSep 26, 2019False Positive Result; False Positive Result

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THE HCG CASSETTE ARE HAVING FALSE POSITIVE RESULTS. ALTHOUGH REQUESTED, NO OTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 9121588 ↗
• MalfunctionSep 24, 2019False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE ASSISTANT ADMINISTERING THE HCG PREGNANCY TESTS WAS FINDING THAT APPROXIMATELY THREE OR FOUR PATIENT RESULTS WERE A FALSE POSITIVE. THEY WERE PERFORMING ULTRASOUNDS AT THE TIME AND KNEW THAT THE PATIENT WAS NOT PREGNANT. THE SAME LOT NUMBER WAS USED ON ALL PATIENTS. THERE WAS NO REPORT OF TREATMENT GIVEN OR WITHHELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114336 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  THE CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE HCG RESULTS ON SIX PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTE BETWEEN 09/27/2018 AND 10/03/2018. PER THE CUSTOMER, FOUR OF THE SIX PATIENTS REPORTED RECEIVING A POSITIVE RESULT ON A HOME PREGNANCY TEST AND ONE PATIENT HAD PROOF OF PREGNANCY. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PATIENTS RECEIVED A POSITIVE HOME PREGNANCY TEST RESULT AND WHICH HAD PROOF OF PREGNANCY. ALL PATIENTS WERE REFERRED TO THEIR PHYSICIANS AS THE FACILITY PROVIDES A FREE SCREENING SERVICE BUT DOES NOT TREAT PATIENTS. ALTHOUGH ATTEMPTED, THE CUSTOMER DECLINED TROUBLESHOOTING BUT WAS SENT A PRODUCT INFORMATION NOTICE REAFFIRMING CURRENT LABELING. A SEPARATE MDR WILL BE FILED FOR EACH REPORTED PATIENT. PLEASE REFER TO MDR#S 2027969-2018-00144 TO 2027969-2018-00148 FOR ALTERNATE FIVE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025751 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  THE CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE HCG RESULTS ON SIX PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTE BETWEEN (B)(6) 2018 AND (B)(6) 2018. PER THE CUSTOMER, FOUR OF THE SIX PATIENTS REPORTED RECEIVING A POSITIVE RESULT ON A HOME PREGNANCY TEST AND ONE PATIENT HAD PROOF OF PREGNANCY. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PATIENTS RECEIVED A POSITIVE HOME PREGNANCY TEST RESULT AND WHICH HAD PROOF OF PREGNANCY. ALL PATIENTS WERE REFERRED TO THEIR PHYSICIANS AS THE FACILITY PROVIDES A FREE SCREENING SERVICE BUT DOES NOT TREAT PATIENTS. ALTHOUGH ATTEMPTED, THE CUSTOMER DECLINED TROUBLESHOOTING BUT WAS SENT A PRODUCT INFORMATION NOTICE REAFFIRMING CURRENT LABELING. A SEPARATE MDR WILL BE FILED FOR EACH REPORTED PATIENT. PLEASE REFER TO MDR#S 2027969-2018-00144 TO 2027969-2018-00147 AND 2027969-2018-00149 FOR ALTERNATE FIVE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025706 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  THE CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE HCG RESULTS ON SIX PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTE BETWEEN 09/27/2018 AND 10/03/2018. PER THE CUSTOMER, FOUR OF THE SIX PATIENTS REPORTED RECEIVING A POSITIVE RESULT ON A HOME PREGNANCY TEST AND ONE PATIENT HAD PROOF OF PREGNANCY. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PATIENTS RECEIVED A POSITIVE HOME PREGNANCY TEST RESULT AND WHICH HAD PROOF OF PREGNANCY. ALL PATIENTS WERE REFERRED TO THEIR PHYSICIANS AS THE FACILITY PROVIDES A FREE SCREENING SERVICE BUT DOES NOT TREAT PATIENTS. ALTHOUGH ATTEMPTED, THE CUSTOMER DECLINED TROUBLESHOOTING BUT WAS SENT A PRODUCT INFORMATION NOTICE REAFFIRMING CURRENT LABELING. A SEPARATE MDR WILL BE FILED FOR EACH REPORTED PATIENT. PLEASE REFER TO MDR#S 2027969-2018-00144 TO 2027969-2018-00146, 2027969-2018-00148, AND 2027969-2018-00149 FOR ALTERNATE FIVE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025668 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  THE CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE HCG RESULTS ON SIX PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTE BETWEEN 09/27/2018 AND 10/03/2018. PER THE CUSTOMER, FOUR OF THE SIX PATIENTS REPORTED RECEIVING A POSITIVE RESULT ON A HOME PREGNANCY TEST AND ONE PATIENT HAD PROOF OF PREGNANCY. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PATIENTS RECEIVED A POSITIVE HOME PREGNANCY TEST RESULT AND WHICH HAD PROOF OF PREGNANCY. ALL PATIENTS WERE REFERRED TO THEIR PHYSICIANS AS THE FACILITY PROVIDES A FREE SCREENING SERVICE BUT DOES NOT TREAT PATIENTS. ALTHOUGH ATTEMPTED, THE CUSTOMER DECLINED TROUBLESHOOTING BUT WAS SENT A PRODUCT INFORMATION NOTICE REAFFIRMING CURRENT LABELING. A SEPARATE MDR WILL BE FILED FOR EACH REPORTED PATIENT. PLEASE REFER TO MDR#S 2027969-2018-00144, 2027969-2018-00145, AND 2027969-2018-00147 TO 2027969-2018-00149 FOR ALTERNATE FIVE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025564 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  THE CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE HCG RESULTS ON SIX PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTE BETWEEN (B)(6) 2018 AND (B)(6) 2018. PER THE CUSTOMER, FOUR OF THE SIX PATIENTS REPORTED RECEIVING A POSITIVE RESULT ON A HOME PREGNANCY TEST AND ONE PATIENT HAD PROOF OF PREGNANCY. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PATIENTS RECEIVED A POSITIVE HOME PREGNANCY TEST RESULT AND WHICH HAD PROOF OF PREGNANCY. ALL PATIENTS WERE REFERRED TO THEIR PHYSICIANS AS THE FACILITY PROVIDES A FREE SCREENING SERVICE BUT DOES NOT TREAT PATIENTS. ALTHOUGH ATTEMPTED, THE CUSTOMER DECLINED TROUBLESHOOTING BUT WAS SENT A PRODUCT INFORMATION NOTICE REAFFIRMING CURRENT LABELING. A SEPARATE MDR WILL BE FILED FOR EACH REPORTED PATIENT. PLEASE REFER TO MDR#S 2027969-2018-00144 AND 2027969-2018-00146 TO 2027969-2018-00149 FOR ALTERNATE FIVE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025483 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  THE CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE HCG RESULTS ON SIX PATIENTS USING THE HENRY SCHEIN HCG URINE CASSETTE BETWEEN 09/27/2018 AND 10/03/2018. PER THE CUSTOMER, FOUR OF THE SIX PATIENTS REPORTED RECEIVING A POSITIVE RESULT ON A HOME PREGNANCY TEST AND ONE PATIENT HAD PROOF OF PREGNANCY. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PATIENTS RECEIVED A POSITIVE HOME PREGNANCY TEST RESULT AND WHICH HAD PROOF OF PREGNANCY. ALL PATIENTS WERE REFERRED TO THEIR PHYSICIANS AS THE FACILITY PROVIDES A FREE SCREENING SERVICE BUT DOES NOT TREAT PATIENTS. ALTHOUGH ATTEMPTED, THE CUSTOMER DECLINED TROUBLESHOOTING BUT WAS SENT A PRODUCT INFORMATION NOTICE REAFFIRMING CURRENT LABELING. A SEPARATE MDR WILL BE FILED FOR EACH REPORTED PATIENT. PLEASE REFER TO MDR#S 2027969-2018-00145 TO 2027969-2018-00149 FOR ALTERNATE FIVE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025419 ↗