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FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0145Recalls & reported problems

Biofire Diagnostics, LLC · IVD reagent kit containing 6 tests · Class 2

All models of FilmArray Pneumonia Panel (Pneumo) (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K180966, K212727, K243222); they may or may not involve this specific model.

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. Aug 12, 2026Open, Classified

    Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

    Z-0148-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Jun 7, 2021Class IITerminated

    Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

    Z-2039-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Jun 7, 2021Class IITerminated

    Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

    Z-2040-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180966, K212727, K243222. One submission often covers many models, so check the product and lot details in each record.

  • Z-0149-2027 · Aug 12, 2026 · Open, Classified
    Generic Name: FilmArray Pneumonia Panel plus Generic Name: FilmArray Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A
  • Z-1518-2025 · Feb 27, 2025 · Open, Classified
    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
  • Z-0994-2024 · Dec 14, 2023 · Open, Classified
    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
  • Z-2440-2023 · May 8, 2023 · Open, Classified
    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
  • Z-1944-2021 · Apr 16, 2021 · Terminated
    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Other Respiratory Panel devices

All Respiratory Panel devices →

Sources and updates

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