FDA Device recall Z-2039-2021
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 0…
- FDA Device
- Class II
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 0… by Biofire Diagnostics, citing due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2039-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-07 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
Reason
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
Identifiers
| code_info | Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2021%22
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