FDAJuly 20, 2021device
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
What to do
FDA enforcement status: Terminated
Brands named
biofire diagnosticsbiofire
UPCs
0081538102008600815381020093
Recall history
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- 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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