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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix NMIC306 Panel

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  Class 2 Device Recall BD Phoenix NMIC306 Panel see related information
Date Initiated by Firm February 29, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1398-2024
Recall Event ID 94180
510(K)Number K132674  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
Code Information UDI-DI: (10) 3318700 (17)241107 (30)0025 (01) 30382904492923 Lot Number: 3318700 Exp. Date: 07-NOV-2024
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		 Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
FDA Determined
Cause 2		 Under Investigation by firm
Action BD issued URGENT: Medical Device Product Correction Product Removal letter on 2/29/24 via courier service via tracked letter and/or e-mail. Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood. 3. Share and post this customer 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 will issue product replacements following receipt of the completed Customer Response Form. Contact: 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 Product Advisory, Recall Questions, Product Complaints, Technical Questions
Quantity in Commerce 11,800 eaches
Distribution Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.
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 and Company
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