FDA Device recall Z-0150-2027
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30…
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30… by Biofire Diagnostics, citing due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0150-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-12 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular 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
Identifiers
| code_info | Lot Code: UDI Nos 00815381020192 (30 Kit), 00815381020208 (6 Kit); Model Nos RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 K…Lot Code: UDI Nos 00815381020192 (30 Kit), 00815381020208 (6 Kit); Model Nos RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit); Lot Numbers 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, 1684726 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by Biofire Diagnostics
- Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), R…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
FDA Device · Class II · 2026-08-19 · Biofire Diagnostics - BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics
All Biofire Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0150-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.