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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL GCLect Agar

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 Class 2 Device Recall BD BBL GCLect Agarsee related information
Date Initiated by FirmJune 21, 2018
Create DateAugust 17, 2018
Recall Status1 Terminated 3 on July 09, 2019
Recall NumberZ-2869-2018
Recall Event ID 80573
510(K)NumberK864803 
Product Classification Culture media, for isolation of pathogenic neisseria - Product Code JTY
ProductBD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.
Code Information 8110781
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information ContactCustomer Service
800-638-8663
Manufacturer Reason
for Recall		A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, BD Diagnostic System, sent an "URGENT MEDICAL DEVICE PRODUCT RECALL" letter dated June 21, 2018, to its customers via UPS, to the attention of Microbiology Manager/Supervisor. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: I. Complete the 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. 2. Discard any remaining inventory of lot 8110781 . BD will process replacement of any discarded inventory upon receipt of the Customer Response Form. 3. Share this Recall Letter with all users of the product within your facility to ensure awareness. BD has identified the root cause of this situation and has initiated corrective actions to prevent recurrence in the future. If you require further assistance, please contact: 800-638-8663 Customer/Technical Support Monday- Friday between 7:00am and 7:00pm (EST) in the United States.
Quantity in Commerce10,360 plates
DistributionUS Distribution in states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, ID, IN, KS, KY, MA, MI, MS, MT, NC, JH, NY, OK, OR, PA, SC, TN, TX, WA, and WI.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JTY
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