Aptima® KIT, BOX 1, REFRIGERATED, ACV/TV, 100T, IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15420045512061), received between Feb 6, 2025 and Mar 12, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Imprecise or Erratic Results

  ON (B)(6) 2026, CUSTOMER REPORTED RUNNING PREVIOUSLY TESTED NEGATIVE SAMPLES WITH THE APTIMA CV/TV ASSAY ON THEIR PANTHER INSTRUMENT (SN (B)(6)) AND RECEIVING POSITIVE RESULTS FROM THE SAME SAMPLE TUBES. CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ON THE NATURE OF THE SAMPLES, WORKLISTS, OR THE INITIAL OR RETEST RESULTS. LIKEWISE, CUSTOMER DID NOT PROVIDE INFORMATION ON RESULT REPORTING OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581186 ↗
• InjuryFeb 25, 2026Imprecise or Erratic Results

  ON FEBRUARY 10, 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON TWO SAMPLES WHILE USING THE APTIMA CV/TV ASSAY (ML 910984) ON THEIR PANTHER INSTRUMENT WITH SERIAL NUMBER (SN) (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED THE TWO SAMPLES ON CV/TV WORKLIST (WL) 002503-20260204-95 AND RECEIVED A TRICHOMONAS VAGINALIS (TRICH) NEGATIVE RESULT ON SAMPLE ID (SID) (B)(6) AND A CANDIDA (C) GLABRATA NEGATIVE RESULT ON SID (B)(6). ON (B)(6) 2026, CUSTOMER PERFORMED REPEAT TESTS FOR THESE SAMPLES ON CVTV WL 002503-20260209-19 AND RECEIVED A TRICH POSITIVE RESULT ON SID (B)(6) AND A C. GLABRATA POSITIVE RESULT ON SID (B)(6). CUSTOMER THEN REPEATED ALL NEGATIVE SAMPLES FROM WL 002503-20260204-95 AND RECEIVED TWO MORE SAMPLES WITH DISCREPANT RESULTS. SIDS (B)(6) BOTH INITIALLY RESULTED TRICH NEGATIVE. ON (B)(6) 2026, CUSTOMER PERFORMED A REPEAT TEST AND RECEIVED A TRICH POSITIVE RESULT FOR SID (B)(6) ON CV/TV WL 002503-20260210-14 AND A TRICH POSITIVE RESULT FOR SID (B)(6) ON CV/TV WL 002503-20260210-17. CUSTOMER DECIDED THAT ALL SAMPLES FROM THE INITIAL CV/TV WL 002503-20260204-95 WILL BE RESULTED AS INDETERMINATE. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447590 ↗
• InjuryAug 13, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED A DISCREPANT RESULT USING APTIMA CV/TV ASSAY MASTER LOT 913344 WHEN TESTING SAMPLES ON PANTHER FUSION PLUS INSTRUMENTS. ON (B)(6) 2025, TWO SAMPLES FROM THE SAME PATIENT WERE TESTED ON CV/TV WL-003679-20250711-09 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TV POSITIVE WHILE SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TV NEGATIVE. CUSTOMER REPORTED BOTH RESULTS TO THE PHYSICIAN/PATIENT. ON (B)(6) 2025, BOTH SAMPLES WERE RETESTED ON CV/TV WL-004306-20250716-08 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6). SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TC POSITIVE AGAIN BUT SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TV POSITIVE. ON THE SAME DAY THE CUSTOMER RETESTED SID (B)(6) ONE MORE TIME ON CV/TV WL-004304-20250716-03 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RESULTED CV NEGATIVE / TV POSITIVE AGAIN. CUSTOMER NOTED THEY WOULD AMEND THE SID (B)(6) RESULT TO CV NEGATIVE / TV POSITIVE. CUSTOMER DID NOT HAVE ANY INFORMATION RELATED TO PATIENT TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22799343 ↗
• InjuryFeb 6, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA CV/TV ASSAY MASTER LOT: 907460 AND APTIMA TRICHOMONAS VAGINALIS ASSAY MASTER LOT: 904910 ON THE PANTHER INSTRUMENT. SAMPLE IDS#: (B)(6) WERE PART OF A CLUSTER OF FIVE POSITIVE TESTS, INITIALLY DETECTED AS TV POSITIVE USING THE APTIMA CV/TV ASSAY. THE CUSTOMER QUESTIONED THESE RESULTS AND RETESTED THE CLUSTER OF FIVE POSITIVE SAMPLES. UPON RETEST, SAMPLE IDS#: (B)(6) RESULTED TV NEGATIVE USING APTIMA TRICHOMONAS VAGINALIS ASSAY. HOLOGIC TECHNICAL SUPPORT (TS) MADE THREE ATTEMPTS TO CONTACT THE CUSTOMER TO DETERMINE IF THE RESULTS WERE REPORTED TO EITHER THE PHYSICIAN OR THE PATIENT BUT WAS UNABLE TO REACH THE CUSTOMER. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323284 ↗