APTIMA AC2, ROOM TEMP, 250T, READY MADERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15420045514966), received between Sep 3, 2024 and Mar 24, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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.

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.

• MalfunctionMar 24, 2025Off-Label Use; Off-Label Use

  CUSTOMER QUESTIONED THEIR RESULTS WITH HOLOGIC¿S APTIMA COMBO 2 READY-MADE-REAGENTS ASSAY (MASTER LOT 909330) AS THEY HAD LOWER THAN EXPECTED RLUS FOR THEIR CHLAMYDIA (CT) POSITIVE CONTROLS ACROSS AT LEAST SIX PANTHER INSTRUMENTS (SERIAL NUMBERS: (B)(6), WITH THE LAST NOT REPORTED) WHERE THEY SUSPECTED A CONTAMINATION ISSUE. CUSTOMER PERFORMED CLEANING OF TOUCHPOINT AREAS WITH 50% BLEACH SOLUTION (WHICH IS OFF-LABEL AS THE HOLOGIC PACKAGE INSERT DETAILS A CONCENTRATION OF 2.5-3.5%) AND REPORTED THAT THE ISSUE PERSISTED. CUSTOMER REPORTED OUT THE RESULTS, WITH CUSTOMER LAST REPORTING THEY HAVE NOT AMENDED ANY RESULTS. CUSTOMER HAS NOT REPORTED THAT THEY PLAN TO AMEND RESULTS, AND NO RETESTING OF SAMPLES IS KNOWN. CUSTOMER DID NOT UPLOAD COMPREHENSIVE LOG FILES. THE FOLLOWING WORKLIST INFORMATION IS KNOWN: (B)(6) ¿ 6 CT POSITIVE SAMPLES (B)(6) ¿ 8 CT POSITIVE SAMPLES (B)(6) ¿ 13 CT POSITIVE SAMPLES (B)(6) ¿ 2 CT POSITIVE SAMPLES OF THE POSITIVES, NONE HAD RLUS ABOVE 1000. TECHNICAL SUPPORT REVIEWED UPLOADED INFORMATION AND FOUND THERE WAS POSSIBLE INHIBITION, INDICATING THE POTENTIAL FOR FALSE NEGATIVE RESULTS, AND ADVISED CUSTOMER TO DISCARD OPEN ITEMS, TO CLEAN ALL SAMPLE AND REAGE

  Patient problems: Insufficient Information

  MAUDE report 21684459 ↗
• InjuryMar 7, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON FEBRUARY 10TH, 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA COMBO 2 ASSAY (ML 908987), WORKLIST 001320-20250205-09, ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER NOTED THE SAMPLE WAS INITIALLY RAN ON WORKLIST 001222-20250204-34 ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) USING THE SAME ASSAY AND OBTAINED A CT NEGATIVE AND GC EQUIVOCAL RESULT. CUSTOMER RETESTED THE SAMPLE ON WORKLIST 001320-20250205-09 (AS PREVIOUSLY MENTIONED) AND OBTAINED A CT POSITIVE AND GC NEGATIVE RESULT. CUSTOMER RETESTED THE SAMPLE FOR A SECOND TIME ON WORKLIST 011015-20250205-41 ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) USING THE SAME ASSAY AND OBTAINED A CT POSITIVE AND GC NEGATIVE RESULT. CUSTOMER NOTED THAT THEY REPORTED OUT THE INITIAL CT NEGATIVE GC EQUIVOCAL RESULT TO THE PATIENT. CUSTOMER WAS NOT PROVIDED ANY TREATMENT INFORMATION OF THE PATIENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553354 ↗
• InjuryNov 6, 2024Difficult to Open or Close; Difficult to Open or Close

  ON OCTOBER 9, 2024, CUSTOMER RELAYED TO HOLOGIC THAT TECHNICIANS HAD HURT THEIR HANDS, ALLEGEDLY BY UNCAPPING OF HOLOGIC AC2 READY-MADE-REAGENT (RMR) BOTTLES. UPON FURTHER INQUIRY, HOLOGIC BECAME AWARE THAT A TECHNICIAN HAD REPORTED WRIST STRAIN ON (B)(6) 2024, AND WAS NOT ABLE TO RETURN TO FULL WORK ACTIVITY UNTIL (B)(6) 2024. AS OF (B)(6)2024, THE TECHNICIAN WAS STILL GOING THROUGH MEDICAL CHECKS EVERY TWO WEEKS.

  Patient problems: Insufficient Information

  MAUDE report 20621111 ↗
• InjurySep 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON AUGUST 6, 2024, CUSTOMER RELAYED TO HOLOGIC THAT IN JUNE 2024 TWO TECHNICIANS WENT TO URGENT CARE FOR HAND/WRIST PAIN FOR THE RIGHT HAND, ALLEGEDLY CAUSED BY THE UNCAPPING OF HOLOGIC READY-MADE-REAGENT (RMR) BOTTLES. THE TECHNICIANS SUBSEQUENTLY RECEIVED PHYSICAL THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 20132104 ↗