FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Check against the official notice below — it lists the full affected range.
BioFire Diagnostics, LLC is recalling 29 FilmArray Blood Culture Identification (BCID) Panel kits distributed nationwide in Florida, Michigan, New Jersey, Ohio, Virginia, and Wisconsin. The recall was initiated due to complaints of false negative results (dropouts) from the blood culture identification panel, potentially caused by a pouch manufacturing error. The affected kits have Part Numbers RFIT-ASY-0126 or RFIT-ASY-0127, Kit Lot# 0868221, Pouch Lot# 194Z21, and Batch 003.
The recall affects a limited number of kits that may produce inaccurate test results. According to the recall record, no specific remedy or consumer action is specified.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Reason for recall: Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error. Distribution: U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None Quantity: 29 kits Lot/code info: Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.