BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerob
Summary
The FDA issued a Class II for BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identif by Becton Dickinson & Co.. Reason: Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility test.
Details
Source
Device Recall
External ID
Z-0232-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
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
Lot/Code Info: UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023
Quantity Affected: 13,900 EA
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-13
Company
Sparks, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Co. have FDA actions?
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0232-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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