BioFire Respiratory Panel 2 — Class II medical device recall Z-2439-2023
Ongoing recall by BioFire Diagnostics, LLC, reported 2023-08-30, distributed in CA, CO, CT, FL, GA, IA, IL, IN…. Due to manufacturing issue, panels may result in false negative results.
| Recall number | Z-2439-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2023-05-08 |
| Classified | 2023-08-21 |
| Reported by FDA | 2023-08-30 |
| Distributed | CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, TN, UT, WV |
| Countries outside the US | CA, CO, IN, JP, SG |
| UPC / GTIN / UDI-DI | 00815381020482 |
| Lot numbers | 2118722, 2151022, 2151722, 2152222, 2152422, 2152722, 2154622, 2154822, 2155022, 2156822, 2157222, 2157922, 2158122, 2162522, 2162622, 2163022, 2164622, 2166622, 2167922, 2168222, 2168322, 2170622, 2170722, 2171122, 2171222, 2171922, 2MRG22, 2N0Z22, 2N1622, 2N1B22, 2N1D22, 2N1G22, 2N2122, 2N2322, 2N2522, 2N2P22, 2N2T22, 2N3022, 2N3222, 2N4C22 and 12 more |
| Model numbers | 423742 |
| Expiration dates | 2023-11-12, 2023-11-19, 2023-11-20, 2023-11-21, 2023-11-22, 2023-11-23, 2023-11-26, 2023-11-27 |
Product
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Reason for recall
Due to manufacturing issue, panels may result in false negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2439-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.