Gram-Negative Bacteria And Associated Resistance Markers — Class II medical device recall Z-1157-2021
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-1157-2021 |
|---|---|
| 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 | 21,922 kits |
| Pathogens | pseudomonas |
| UPC / GTIN / UDI-DI | 00815381020086, 00815381020093 |
| Model numbers | 442020, 442023, RFIT-ASY-0126, RFIT-ASY-0127 |
Product
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only
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-1157-2021. 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.