BioFire BCID2 Panel — Class II medical device recall Z-1158-2021
Terminated recall by BioFire Diagnostics, LLC, reported 2021-03-10, distributed nationwide. The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are
| Recall number | Z-1158-2021 |
|---|---|
| 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 | 2021-01-26 |
| Classified | 2021-03-01 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2022-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, EC, EE, EG, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IL, IN, IT, JO, JP, KE, KR, KW, LB, LV, MA, MX, MY, NI, NL, PA, PE, PH, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UY, VN |
| Quantity | 5,220 kits |
| Pathogens | pseudomonas |
| UPC / GTIN / UDI-DI | 00815381020338 |
| Model numbers | 442020, 442023, RFIT-ASY-0147 |
Product
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
Reason for recall
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
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-1158-2021. 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.