Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0232-2023 — BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref)

U.S. FDA — Device Enforcement · United States · 2022-10-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0232-2023
Date of alert
2022-10-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton Dickinson & Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30382904486076
Reported risk: Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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