№ files_lp_4_process_1_35921
File format: docx Character count: 5391 File size: 121 KB
Mandatory notification to laboratories regarding software update to the BIOFIRE BCID2 Panel pouch module addressing prior false positive and false negative Candida tropicalis results and updating assay sensitivity data.
Year: 2026
Region / City: Global / Laboratories using BIOFIRE BCID2 Panel
Subject: Laboratory safety update for BIOFIRE BCID2 Panel
Document Type: Safety Notice / Field Correction
Organization: bioMérieux
Product: BIOFIRE BCID2 Panel
Reference Number: RFIT-ASY-0147
Affected Lots: All unexpired lots
Purpose: Mitigation of false negative and false positive Candida tropicalis results
Required Action: Software update of Pouch Module, distribution of updated IFU, acknowledgment form submission
Target Audience: Laboratory Medical Directors, Laboratory Personnel
Date Issued: 2026
Affected Assays: Staphylococcus epidermidis, Candida tropicalis
Instruction Reference: BIOFIRE BCID2 Panel IFU Revision 06
Additional Notes: Emphasizes verification of results in conjunction with Gram stain and presence of non-viable organisms
Price: 8 / 10 USD
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