OSOM Ultra hCG 25T Kit 1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00742860100208), received between Dec 15, 2021 and Jan 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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 23, 2024Class IIOpen, Classified

   This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.

   Z-0259-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026False Positive Result

  THREE PATIENT SERUM SAMPLES YIELDED FALSE-POSITIVE RESULTS ON THE OSOM ULTRA HCG COMBO TEST, WHILE SUBSEQUENT QUANTITATIVE LABORATORY TESTING CONFIRMED THAT ALL THREE PATIENTS WERE HCG-NEGATIVE. ADDITIONAL PATIENT INFORMATION: PATIENT #2, PATIENT IDENTIFIER - CONFIDENTIAL PATIENT AGE: 14 YEAR(S). PATIENT WEIGHT: 81 KG. DATE OF EVENT: (B)(6) 2025. PATIENT #3, PATIENT IDENTIFIER - CONFIDENTIAL. PATIENT AGE: 16 YEAR(S). PATIENT WEIGHT: 65 KG. DATE OF EVENT: (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048386 ↗
• MalfunctionSep 6, 2024False Negative Result; False Negative Result

  ON JULY 30, 2024, THE END USER, A HEALTH CARE PROVIDER, NOTIFIED (B)(6) (DISTRIBUTOR) OF TWO FALSE NEGATIVE HCG RESULTS OBTAINED WITH PATIENT URINE SAMPLES. THE EVENT WAS REPORTED TO PRINCETON BIOMEDITECH CORP. (MANUFACTURER) ON JULY 30, 2024. THE OSOM ULTRA HCG COMBO TEST (KIT), PART NUMBER 1004, LOT 563L13, EXPIRATION 2025-12-31 WAS USED. THE DISTRIBUTOR ASKED THE USER TO RETURN THE KIT FOR INVESTIGATION. THE END USER REPORTED GETTING FALSE NEGATIVE RESULT WITH TWO PATIENT URINE SAMPLES. QUANTITATIVE HCG TESTS WERE PERFORMED AND RESULTING VALUES WERE 177,000 AND 59,000 MIU/ML. BOTH PREGNANCIES WERE CONFIRMED BY ULTRASOUND. THE END USER RETURNED 66 TEST DEVICES ON JULY 31, 2024, FOR FURTHER INVESTIGATION. THE END USER BELIEVED THE FALSE NEGATIVES WERE ISOLATED TO A SINGLE LOT OF OSOM CARTRIDGES AND ONLY OCCURRED IN SOME BOXES. AS THE END USER REPORTED THE ISSUE TO THE DISTRIBUTOR, WHO THEN REPORTED THE ISSUE TO THE MANUFACTURER, WE (MANUFACTURER) DO NOT HAVE ADDITIONAL INFORMATION ABOUT THE PATIENT OR THE END USER. ON AUGUST 15, 2024, OUR INVESTIGATION REVEALED THE ISSUE WAS CAUSED BY A PRODUCT PROBLEM AFFECTING ABOUT 50 TEST DEVICES, ACROSS FEWER THAN 40 BOXES OF PRODUCT. CORRECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164422 ↗
• MalfunctionDec 15, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021, THE CUSTOMER, (B)(6) NOTIFIED (B)(4) (DISTRIBUTOR), VIA VOICEMAIL OF A FALSE NEGATIVE HCG RESULT FOR A PATIENT'S URINE SAMPLE. THE EVENT WAS REPORTED TO PRINCETON BIOMEDITECH CORP. (MANUFACTURER) ON (B)(6) 2021. THE OSOM ULTRA HCG COMBO TEST (KIT), PART NUMBER 1004, LOT 561C23, EXPIRATION 30 APRIL 2023 WAS USED. SEKISUI ASKED THE USER TO RETURN THE KIT FOR INVESTIGATION. THE CUSTOMER REPORTED GETTING A FALSE NEGATIVE RESULT WITH A PATIENT'S URINE SAMPLE. THE URINE SAMPLE WAS NOT THE FIRST MORNING URINE. THE TEST PRODUCED A NEGATIVE RESULT WITHIN THE 3 TO 5 MINUTE READ TIME OF THE ASSAY. AFTER THE 5-MINUTE READ TIME THE CUSTOMER NOTED THAT THE TEST PRODUCED A FAINT POSITIVE TEST LINE. THE TIMING OF HOW LONG THE CASSETTE SAT AFTER THE TEST WINDOW WAS NOT KNOWN AT THE TIME OF THIS ASSESSMENT. A QUANTITATIVE HCG TEST WAS PERFORMED AND RESULTED AS 88.7. NO UNITS OR RESULT CONCLUSION WAS PROVIDED. THE OSOM ULTRA HCG COMBO TEST WAS CONDUCTED AGAIN WITH THE SAME URINE SAMPLE AND IT PRODUCED THE SAME RESULTS; NEGATIVE RESULT WITHIN THE 3 TO 5 MINUTE READ TIME AND A FAINT POSITIVE TEST LINE AFTER THE 5 MINUTE READ TIME. A SECOND QUANTITATIVE HCG WAS RUN THE SAME DAY ((B)(6) 2

  Patient problems: Insufficient Information

  MAUDE report 13014997 ↗