FilmArray Pneumonia Panel plus — Class II medical device recall Z-2040-2021
Terminated recall by BioFire Diagnostics, LLC, reported 2021-07-14, distributed in AK, AL, AZ, CA, CO, CT, DC, DE…. Due to real-time stability study failures resulting in increase rate of false negative results between the 6 t
| Recall number | Z-2040-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2021-06-07 |
| Classified | 2021-07-08 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2023-07-31 |
| Distributed | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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 |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BM, BO, BR, CH, CL, CN, CO, CR, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IL, IN, IQ, IT, JO, JP, KE, KW, LB, LT, LV, MA, MX, MY, NI, NL, NP, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UY, VN, ZA |
| Quantity | 3,559 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00815381020178, 00815381020185, 00815381020314, 00815381020321 |
| Model numbers | RFIT-ASY-0142, RFIT-ASY-0143, RFIT-ASY-0144, RFIT-ASY-0145 |
Product
FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Reason for recall
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
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-2040-2021. 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.