FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: 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.
- Recall number
- Z-2869-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-06-21
- Posted
- not on file
- Terminated
- 2019-07-09
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 8110781
- 510(k) numbers
- ["K864803"]
- PMA numbers
- not on file
- Product code
- JTY
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28