# Class II recall Z-0148-2027: BioFire Diagnostics, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0148-2027 |
| Recalling firm | BioFire Diagnostics, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Generic Name: FilmArray¿ Pneumonia Panel  Generic Name: FilmArray¿ Pneumonia Panel  Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144).  Software Version: N/A  Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)  Component: N/A |
| Reason | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results |
| Quantity | 4,892 |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Unite |
| Recall initiated | 2026-08-12 |
| Reported | 2026-10-21 |
| Firm location | Salt Lake City, UT, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0148-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.