Z-2869-2018Class II

BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery...

Name: Z-2869-2018 BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery...
Creator: Becton Dickinson & Co.
Published: 2018-06-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-06-21 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD 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... on 2018-06-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2869-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Posted: 2018-08-17
Terminated: 2019-07-09
Recalling firm: Becton Dickinson & Co
Product: BD 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.
Product code: JTY Culture Media, For Isolation Of Pathogenic Neisseria
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The 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 commerce: 10,360 plates
Distribution: US 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.
Product codes and lots: 8110781

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2869-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2869-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

Product code JTY

K864803Class IIGc-Lect(tm)Bd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1987-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)