Panther Fusion® KIT, SARS/FLU A/B/RSV REAG CARTRDG, 96T, FUS, IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15420045515352), received between Jun 28, 2023 and Jan 13, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (4 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. Nov 8, 2024Class IIOpen, Classified

   SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

   Z-0694-2025 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Imprecise or Erratic Results; Device Contaminated at the User Facility; Imprecise or Erratic Results; Device Contaminated at the User Facility

  ON DECEMBER 16, 2024, CUSTOMER RELAYED TO HOLOGIC THAT THEY HAD SAMPLE ID (B)(6) RESULT AS SARS-COV-2 AND RSV POSITIVE WITH OUR FUSION SARS-COV-2/FLU A/B/RSV ASSAY (CARTRIDGE LOT 887495) ON THEIR PANTHER FUSION (SN (B)(6)) UNDER WORKLIST ID (B)(6) WHERE THE SAME SAMPLE REPEATED AS ONLY RSV POSITIVE WHEN RETESTED ON THE PANTHER FUSION UNDER THE SAME WORKLIST ID. THE DUAL POSITIVE RESULT WAS AUTOMATICALLY REPORTED OUT BEFORE BEING AMENDED TO BEING ONLY RSV POSITIVE. THE SAMPLE WAS FROM THE EMERGENCY/URGENT CARE WARD. INFORMATION ABOUT ANY TREATMENT PERFORMED IS UNKNOWN AND CASE TROUBLESHOOTING IS ONGOING AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137774 ↗
• InjuryDec 30, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  FOLLOW-UP REPORT. SEE SECTION H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044637 ↗
• InjurySep 19, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  ON 08/22/2024, QUEST DIAGNOSTICS CUSTOMER SITE REPORTED TO HOLOGIC THAT THEY HAD FALSE POSITIVE FLU-B RESULTS ACROSS MULTIPLE WORKLISTS (WL) WHILE USING THE SARS/FLU A/B/RSV ASSAY (CARTRIDGE LN 887424) (ML 890419) ON PANTHER FUSION INSTRUMENT (SN (B)(6). CUSTOMER REPORTED MULTIPLE FLU B AND SARS-COV-2 DUAL POSITIVE RESULTS IN THE LAST FEW RUNS. CUSTOMER RETESTED THE ASSOCIATED SARS-COV-2 AND FLU B DUAL POSITIVE SAMPLES ON THEIR OTHER PANTHER FUSION INSTRUMENT (B)(6), WHICH RESULTED IN SARS-COV-2 POSITIVE AND FLU B NEGATIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263844 ↗
• MalfunctionDec 12, 2023False Positive Result; False Positive Result

  FOLLOW-UP REPORT. SEE SECTION H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314887 ↗
• MalfunctionNov 2, 2023False Positive Result; False Positive Result

  ON 10/06/2023, HOLOGIC WAS MADE AWARE OF A CUSTOMER WHO QUESTIONED THE SAMPLE RESULTS FOR THEIR SARS/FLU A/B/RSV ASSAY EVALUATION FOR THEIR PANTHER FUSION INSTRUMENT (SN (B)(6) ). A CLINICAL PROFICIENCY SAMPLE WAS INITIALLY RUN ON (B)(6) 2023 USING REAGENT CARTRIDGE LOT 337024 AND RESULTED POSITIVE FOR SARS AND FLU B, WHICH WENT AGAINST THE EXPECTED RESULT OF A SINGLE SARS POSITIVE. THE CUSTOMER REPEATED THE SAMPLE ON (B)(6) 2023 ON THE SAME INSTRUMENT AND GOT ANOTHER DUAL POSITIVE RESULT FOR SARS AND FLU B. UPON FURTHER REVIEW OF THE INSTRUMENT LOGS, CUSTOMER NOTED THAT OUT OF 40 SAMPLES TESTED THAT WERE SARS POSITIVE, 31 OF THOSE SAMPLES WERE ALSO POSITIVE FOR FLU B. CUSTOMER QUESTIONED THE VALIDITY OF THESE SAMPLE RESULTS AND IF THE INSTRUMENT THERMOCYCLER MAY HAVE CONTRIBUTED TO THE SUSPECT RESULTS. THE CUSTOMER DID NOT INFORM HOLOGIC OF ANY RESULTS REPORTED TO PATIENTS, ANY CORRECTIONS OR AMENDMENTS TO THESE RESULTS, OR ANY TREATMENT PROVIDED. THERE WERE NO ASSOCIATED OR REPORTED ADVERSE EVENTS. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL APTIMA SARS-COV-2 ASSAY QUESTIONING RESULTS AND FALSE RESULTS (CONFIRMED OR NOT) COMPLAINTS TO BE REPORTED AS MALFUNCTION MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18061854 ↗
• MalfunctionNov 2, 2023Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2023, THE CUSTOMER REPORTED TO HOLOGIC THAT THEY SUSPECTED ONE SAMPLE WAS A FALSE POSITIVE FOR SARS-COV-2, FLU A, AND RSV. THE CUSTOMER WAS USING THE SARS-COV-2/FLU A/B/RSV ASSAY, REAGENT CARTRIDGE LOT 884490, ON THE PANTHER FUSION INSTRUMENT (SN (B)(6) ). THE SAMPLE IN QUESTION WAS INITIALLY TESTED ON (B)(6) 2023 AND RESULTED POSITIVE FOR SARS-COV-2, FLU A, AND RSV. CUSTOMER QUESTIONED THE SAMPLE RESULT SINCE ALL POSITIVE ANALYTES HAD SIMILAR CT VALUES. THE SAME SAMPLE TUBE WAS RETESTED ON A NON-HOLOGIC PLATFORM THE SAME DAY AND RESULTED NEGATIVE FOR SARS-COV-2, FLU A, AND RSV. ONCE THE RESULT ON THE NON-HOLOGIC PLATFORM WAS OBTAINED, THE CUSTOMER CHECKED THE CURVES FOR THIS SAMPLE AND SUSPECTED THAT IT WAS A FALSE TRIPLE POSITIVE. CUSTOMER THEN RETESTED THE SAME SAMPLE TUBE AND A NEW FUSION TUBE, BOTH TIMES RESULTING NEGATIVE FOR ALL FOUR ANALYTES. THE TRIPLE POSITIVE RESULT WAS REPORTED TO THE PATIENT, WHICH GOES AGAINST THE SARS-COV-2/FLU A/B/RSV ASSAY PACKAGE INSERT TO RETEST THE SAMPLE AND CONFIRM RESULTS SINCE TRIPLE INFECTIONS ARE RARE. THE CUSTOMER COULD NOT CONFIRM WHETHER THE PATIENT RECEIVED TREATMENT OR IF THE RESULT WAS AMENDED. THERE WERE NO ASSOCIATED/REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057967 ↗
• MalfunctionJun 28, 2023Device Contaminated at the User Facility; Device Contaminated at the User Facility

  CUSTOMER PERFORMED ONE SARS/FLUA/B/RSV RUN, WL: 000238-20230621-03 ((B)(62023), USING ASSAY LOT 343968 ON PANTHER FUSION INSTRUMENT SN (B)(6) WHICH HAD 2 QUESTIONING SAMPLES. CUSTOMER RETESTED 2 INITIALLY POSITIVE RESULTS (WL: 000238-20230619-07 ((B)(6)2023)) USING THE SAME SAMPLE TUBE WITH A NEW PIERCEABLE CAP, NEW SAMPLE ALIQUOT, AND SAME ASSAY LOT AND OBTAINED SUBSEQUENT NEGATIVE RESULTS FOR BOTH SAMPLES (WL: 000238-20230621-03 ((B)(6)2023). THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. CUSTOMER CONFIRMED THAT ONLY THE SUBSEQUENT NEGATIVE RESULT WAS REPORTED OUT. CUSTOMER DID NOT NOTE HAVING INFORMATION IF THE PATIENT RECEIVED TREATMENT BASED ON THE REPORTED RESULTS. THERE WERE NO ASSOCIATED ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 17219474 ↗