FDAJune 10, 2024device
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
What to do
FDA enforcement status: Ongoing
Brands named
biofire diagnosticsbiofire
UPCs
00815381020314
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay2026-05-07
- FDAdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-22026-04-30
- FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.2026-04-22
- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
- FDABiofire Spotfire Respiratory/Sore Throat Panel REF: 4234852026-04-01
- FDADimension Creatinine Flex reagent cartridge. Material Number: 10872079.2026-03-18
- FDALeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) ...2026-03-13
- FDA(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the fo...2026-03-13
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