—#197247

Product

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

FDA product code: JTY — Culture Media, For Isolation Of Pathogenic Neisseria
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 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).

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

Timeline

Recall initiated: 2022-11-21
Posted by FDA: 2022-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.