BioFire® Respiratory Panel 2.1 423742Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815381020529), received between May 22, 2025 and Sep 30, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (3 reports).

3 FDA recall records name this device's identifier, 3 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. Jun 24, 2026Class IIOpen, Classified

   Due to increase in false negative results

   Z-2936-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 22, 2025Class IIOpen, Classified

   Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

   Z-0602-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Nov 27, 2023Class IIOpen, Classified

   A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

   Z-0704-2024 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjurySep 30, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  SUMMARY: (B)(6) INFORMED BIOFIRE THAT THE VACUUM SEAL ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING. THE CUSTOMER STATED THAT IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS HAS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL SYNDROME AND OTHER RELATED INJURIES. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS HAVE NOT BEEN PROVIDED AT THIS TIME. BIOFIRE IS SUBMITTING THREE INDIVIDUAL MEDICAL DEVICE REPORTS (MDRS), ONE FOR EACH AFFECTED INDIVIDUAL AS REPORTED BY THE CUSTOMER. THIS MDR (3002773840-2025-00074) PERTAINS TO INDIVIDUAL #3. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23187378 ↗
• InjurySep 30, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  SUMMARY: (B)(6) INFORMED BIOFIRE THAT THE VACUUM SEAL ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING. THE CUSTOMER STATED THAT IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS HAS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL SYNDROME AND OTHER RELATED INJURIES. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS HAVE NOT BEEN PROVIDED AT THIS TIME. BIOFIRE IS SUBMITTING THREE INDIVIDUAL MEDICAL DEVICE REPORTS (MDRS), ONE FOR EACH AFFECTED INDIVIDUAL AS REPORTED BY THE CUSTOMER. THIS MDR (3002773840-2025-00073) PERTAINS TO INDIVIDUAL #2. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23187377 ↗
• InjurySep 30, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  SUMMARY: (B)(6) INFORMED BIOFIRE THAT THE VACUUM SEAL ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING. THE CUSTOMER STATED THAT IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS HAS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL SYNDROME AND OTHER RELATED INJURIES. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS HAVE NOT BEEN PROVIDED AT THIS TIME. BIOFIRE IS SUBMITTING THREE INDIVIDUAL MEDICAL DEVICE REPORTS (MDRS), ONE FOR EACH AFFECTED INDIVIDUAL AS REPORTED BY THE CUSTOMER. THIS MDR (3002773840-2025-00072) PERTAINS TO INDIVIDUAL #1. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23187375 ↗
• InjuryMay 22, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) RESULT AND A FALSE POSITIVE CORONAVIRUS 229E ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE RP2.1 RESULT, THE PATIENT WAS NOT TREATED AND EXPERIENCED RESPIRATORY FAILURE. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN BIOFIRE RP2.1 AND A COMPARATOR METHOD.

  Patient problems: Respiratory Failure

  MAUDE report 22074228 ↗