Recall Z-0232-2023— Becton Dickinson & Co.

Name: FDA recall Z-0232-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-13

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2022-10-13. It names one FDA 510(k) clearance: K070809. Product: 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) Number: 448607. Reason: 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.

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-13
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K070809 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/MLBecton, Dickinson & CO·cleared 2007-09-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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) Number: 448607

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.