Recall Z-1398-2024

Becton Dickinson & Co. · initiated February 29, 2024

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: UDI-DI: (10) 3318700 (17)241107 (30)0025 (01) 30382904492923 Lot Number: 3318700 Exp. Date: 07-NOV-2024

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: Under Investigation by firm

Action taken

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

Details

Recall number
Z-1398-2024
Initiated
February 29, 2024
Posted by FDA
March 29, 2024
Product code
LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Quantity
11,800 eaches
Distribution
Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.
Recalling firm
Becton Dickinson & Co., Sparks, MD

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1399-2024 Class IIBD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated…Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast… 02/29/2024Open, Classified