Z-0232-2023 Class II Ongoing
FDA device recall Z-0232-2023 was initiated by Becton Dickinson & Co. on Oct 13, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 13,900 EA.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2022
- Initiation Date
- Oct 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,900 EA
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
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0232-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026