Aptima Combo 2® KIT, BX 1 (REFRIG) AC2, 100T, AS, IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045505735), received between Sep 12, 2017 and Jan 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FINAL REPORT: A (B)(6) PREVALENCE STUDY WAS INITIATED BY THE (B)(6) IN CONJUNCTION WITH THE (B)(6). ROUTINE SAMPLES THAT TESTED [?]EQUIVOCAL' FOR (B)(6) BY AC2 WERE RE-TESTED BY THE (B)(6) WHICH USES A DIFFERENT DETECTION TARGET (16S RRNA). SAMPLES THAT TESTED ACT (B)(6) WERE FORWARDED TO NMLFOR SEQUENCING TO EXAMINE IF MUTATION(S) IN THE 23S RRNA REGION PRODUCED (B)(6) VARIANT STRAINS. NML IDENTIFIED THREE (B)(6) VARIANT SAMPLES IN OVER 100,000 APTIMA COMBO2 SAMPLES SCREENED; 2 SAMPLES CARRIED THE C1514T MUTATION AND 1 SAMPLE CARRIED THE G1523A MUTATION. THESE MUTATIONS WERE PREVIOUSLY IDENTIFIED IN EUROPE AT VERY LOW PREVALENCE (ROBERTS ET AL., EUROSURVEILLANCE, 2019). THE NUMBER OF AC2 SAMPLES SCREENED WAS NEEDED TO ESTIMATE THE PREVALENCE OF THESE 3 (B)(6) VARIANTS IN (B)(6). DUE TO THE DIFFICULTY EXTRACTING THE NUMBERS FROM EACH LABORATORY'S INFORMATION SYSTEM, HOLOGIC USED CUSTOMER ORDERING DATA (DURING THE (B)(6) SURVEILLANCE PERIOD (JUNE 2019 TO OCTOBER 2019)) TO DETERMINE A VOLUME OF APPROXIMATELY 115,000 SCREENED AC2 SAMPLES. THE ESTIMATED PREVALENCE OF (B)(6) VARIANTS IDENTIFIED THUS FAR IN (B)(6) IS 0.0026%. THIS PREVALENCE RATE IS SIMILAR TO THE 0.003% PREVALENCE SEEN

  Patient problems: Unspecified Infection

  MAUDE report 9572514 ↗
• InjurySep 12, 2017Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) REPORTED THAT THEY HAD ONE AC2 ASSAY RUN WITH MORE POSITIVES THAN NORMAL (GC POSITIVE RATE WAS 1%). THE RUN (CONSISTING OF BOTH SWAB AND URINE SAMPLES) DONE ON THE PANTHER ON (B)(6) 2017 WAS A VALID RUN AND THE LABORATORY SAID THAT THEY DIDN'T IDENTIFY A PATTERN TO THE RUN. THE LABORATORY RELEASED THE RESULTS. A PHYSICIAN QUESTIONED FOUR OF THE RESULTS FOR SWAB AND URINE SAMPLES AND SENT FOR NEW PATIENT COLLECTIONS FOR THESE FOUR QUESTIONABLE RESULTS. ALL FOUR NEWLY COLLECTED SAMPLES WERE TESTED AS NEGATIVE. WHEN LABORATORY HEARD FROM THE PHYSICIAN, THEY CONTACTED HOLOGIC. HOLOGIC REVIEWED THE INSTRUMENT LOGS FOR THE RUN WITH THE HIGHER POSITIVITY RATE WHICH SHOWED NO INSTRUMENT OR REAGENT PREPARATION RELATED ISSUE. THERE WAS NO SIGN OF GROSS CONTAMINATION. HOLOGIC REQUESTED THE SAMPLES BACK (BOTH THE INITIAL SAMPLE WHICH TESTED POSITIVE AND THE SAMPLE TAKEN FROM THE RE-TEST) AND THEY WERE NOT AVAILABLE. HOLOGIC COULD NOT CONFIRM THE INITIAL OR SECONDARY SAMPLE TEST RESULTS. AN INCORRECT RESULT COULD BE DUE TO A KIT OR SAMPLE MISHANDLING ISSUE OR THE SAMPLES COULD BE LOW TITER SAMPLES. HOLOGIC RECOMMENDED CUSTOMER TO DISCARD ALL OPEN KITS AND CLEAN THE LAB. HOLOGIC INVESTIGA

  Patient problems: No Code Available

  MAUDE report 6858600 ↗