BD Onclarity™ HPV Assay Reagent Pack 441990Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382904419905), received between Jan 12, 2023 and Jun 15, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (7 reports).

1 other recall cover devices cleared under the same FDA submission (P160037); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK, A DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TESTING GAVE HPV POSITIVE RESULT. PROVIDER RECOLLECTED SAMPLE AND TESTED AGAIN, AND RESULT WAS NEGATIVE. BOTH INITIAL AND RECOLLECTED SAMPLE WERE RETESTED, AND BOTH WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510765 ↗
• MalfunctionNov 8, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT BD ON CLARITY HPV ASSAY GAVE A POSITIVE RESULT ON ONE PATIENT SAMPLE, SHOWING TWO DASHES INSTEAD OF AN ACCEPTABLE RESULT SYMBOL. CUSTOMER REPEATED AND RESULTS WERE NEGATIVE FOR BOTH ORIGINAL SAMPLE AND A NEW ALIQUOT FROM SUREPATH VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096949 ↗
• MalfunctionAug 7, 2023False Positive Result; False Positive Result

  REPORT 2 OF 3. IT WAS REPORTED THAT BD ONCLARITY HPV ASSAY 3 SPECIMENS WERE RUN AND CAME OUT POSITIVE. AFTER RECOLLECTION THE SPECIMENS CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, 3 SPECIMENS WERE RUN FOR BD ONCLARITY HPV ASSAY AND CAME OUT POS. AFTER RECOLLECTION A COUPLE OF MONTHS APART ALL SPECIMENS WERE NEGATIVE. CUSTOMER SENT ALL 6 SPECIMENS (3 PATIENTS) FOR CONFIRMATION, AND ALL SPECIMENS WERE NEGATIVE EXCEPT 2 WERE INCONCLUSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476456 ↗
• MalfunctionAug 7, 2023False Positive Result; False Positive Result

  REPORT 3 OF 3 IT WAS REPORTED THAT BD ONCLARITY HPV ASSAY 3 SPECIMENS WERE RUN AND CAME OUT POSITIVE. AFTER RECOLLECTION THE SPECIMENS CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, 3 SPECIMENS WERE RUN FOR BD ONCLARITY HPV ASSAY AND CAME OUT POS. AFTER RECOLLECTION A COUPLE OF MONTHS APART ALL SPECIMENS WERE NEGATIVE. CUSTOMER SENT ALL 6 SPECIMENS (3 PATIENTS) FOR CONFIRMATION, AND ALL SPECIMENS WERE NEGATIVE EXCEPT 2 WERE INCONCLUSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475052 ↗
• MalfunctionAug 7, 2023False Positive Result; False Positive Result

  REPORT 1 OF 3 . IT WAS REPORTED THAT BD ONCLARITY HPV ASSAY 3 SPECIMENS WERE RUN AND CAME OUT POSITIVE. AFTER RECOLLECTION THE SPECIMENS CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, 3 SPECIMENS WERE RUN FOR BD ONCLARITY HPV ASSAY AND CAME OUT POS. AFTER RECOLLECTION A COUPLE OF MONTHS APART ALL SPECIMENS WERE NEGATIVE. CUSTOMER SENT ALL 6 SPECIMENS (3 PATIENTS) FOR CONFIRMATION, AND ALL SPECIMENS WERE NEGATIVE EXCEPT 2 WERE INCONCLUSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17474482 ↗
• MalfunctionFeb 8, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING THE BD ONCLARITY HPV ASSAY THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: - CUSTOMER REPORTS THAT 2 POS PATIENT RESULTS FOR HPV TEST WERE QUESTIONED BY A PHYSICIAN, AND THE REPEATS WERE NEG FOR BOTH SAMPLES; - FIRST SAMPLE WAS INITIALLY RAN ON (B)(6) 2022 AND WAS POS FOR GENOTYPE 16; THEN IT WAS REPEATED ON (B)(6) 2023 ON THE SAME VLT0257, AND THE RESULT WAS NEG; SAMPLE WAS STORED AT RT IN THINPREP VIAL; - SECOND SAMPLE WAS INITIALLY TESTED ON VLT0257 ON (B)(6) 2022, AND WAS POS FOR GENOTYPE 31; IT WAS REPEATED "IN TWO WEEKS" ON NON-BD INSTRUMENT, AND WAS NEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318461 ↗
• MalfunctionFeb 2, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING THE BD OCULARITY HPV ASSAY THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: - CUSTOMER REPORTS THAT 2 POS PATIENT RESULTS FOR HPV TEST WERE QUESTIONED BY A PHYSICIAN, AND THE REPEATS WERE NEG FOR BOTH SAMPLES; - FIRST SAMPLE WAS INITIALLY RAN ON 12/27/2022 AND WAS POS FOR GENOTYPE 16; THEN IT WAS REPEATED ON 01/20/2023 ON THE SAME VLT0257, AND THE RESULT WAS NEG; SAMPLE WAS STORED AT RT IN THINPREP VIAL; - SECOND SAMPLE WAS INITIALLY TESTED ON VLT0257 ON 12/19/2022, AND WAS POS FOR GENOTYPE 31; IT WAS REPEATED "IN TWO WEEKS" ON NON-BD INSTRUMENT, AND WAS NEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287893 ↗
• MalfunctionJan 12, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT BD ONCLARITY HPV ASSAY 1 SPECIMEN WAS RUN AND TESTED POSITIVE FOR ALL GENOTYPES. THEY WERE REPEATED AND TESTED NEGATIVE ON THE COR. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAD A FULL HPV RUN AND 1 PATIENT SAMPLE WAS AFFECTED AND SAMPLES WERE POSITIVE FOR ALL GENOTYPES. CUSTOMER RE-ALIQUOT THE SPECIMEN AND REPEATED USING THEIR COR. THE SPECIMEN REPEATED NEGATIVE FOR ALL GENOTYPES AND THE PAP TEST WAS ALSO NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153188 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160037. One submission often covers many models, so check the product and lot details in each record.

• Z-2162-2025 · Jun 23, 2025 · Open, Classified
  BD COR System Software. Model Number: 444829.