Class 2 Device Recall BBL" Chocolate II Agar

• Date Initiated by Firm: November 21, 2022
• Date Posted: December 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0473-2023
• Recall Event ID: 91201
• Product Classification: Culture media, for isolation of pathogenic neisseria - Product Code JTY
• Product: BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species.; Catalog (Ref) Number: 221267
• Code Information: UDI: (10)2206461(17)221125(30)0100 Lot Number: 2206461 Exp. Date: 20221125. Box numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.
• FDA Determined Cause: Under Investigation by firm
• Action: BD initiated the recall on November 21, 2022 via Urgent Medical Device Correction Letter. to Distributors and Risk Managers. Letter states reason for recall, health risk and action to take: Immediately inspect your inventory for the specific catalog and lot number listed above. Affected product includes box numbers 0002 through 0097. These boxes correlate to timestamps on the plates of 11:34 through 13:51. Timestamps can be found on the bottom of the plate. The box number can be located on the 2. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3. 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. Distributors: As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this notification. Email an excel file listing of all customers to BDRC4@bd.com within 72 hours of receipt of this letter so that BD may initiate customer notification. Actions Taken by BD: BD will issue replacements following receipt of the completed Customer Response Form. Questions: North American Regional Complaint Center .Phone: 1-844-8BD-LIFE (1-844-823-5433) Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
• Quantity in Commerce: 9,600 EA
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
• 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.