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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix PMIC/ID107

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  Class 2 Device Recall BD Phoenix PMIC/ID107 see related information
Date Initiated by Firm October 13, 2022
Date Posted November 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0232-2023
Recall Event ID 91010
510(K)Number K070809  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
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
Code Information UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact SAME
410-316-4000
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action BD initiated the recall on October 13, 2022 via Urgent Medical Device Product Advisory states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above and ensure the contents of this Product Advisory are read and understood. 2. It is recommended to suspend reporting of Minocyline AST results to clinicians for the affected lot. 3. Share and post this Product Advisory letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. BD Contact US Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Quantity in Commerce 13,900 EA
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LON and Original Applicant = BECTON, DICKINSON & CO.
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