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FDA (Device enforcement)Recalled 2022-10-13class ii

Becton Dickinson & Co.: 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 hu

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US Nationwide distribution. Quantity: 13,900 EA Lot/code info: UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023

UPC codes

30382904486076

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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