BD BBL Martin-Lewis Agar recallZ-1378-2021 · Becton Dickinson & Co. · initiated Mar 17, 2021

Why it was recalled

Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

FDA root cause category: Under Investigation by firm

What the company is doing

BD issued Urgent Medical Device Correction letter on 3/17/21 to customers and distributors via FedEx tracked letter. Letter states reason for recall, health risk and action to take: 1.Immediately inspect your inventory for the specific catalog and lot numbers listed above. Destroy all products subject to the recall following your institutions process for destruction. 2.Share this recall notification with all users within your facility network to ensure they are also aware of this recall. 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 and subsequently process your product replacement, if required. BD will provide a product replacement for all destroyed inventory. If you require further assistance, please contact: BD Contact US Contact Information Outside of US BD Customer/ Technical Support 800-638-8663 Monday Friday 7:00am and 7:00pm EST For customers outside the US, contact the local BD representative or distributor.

Recall details

Recall number

Z-1378-2021

Status

Terminated

Initiated by the company

Mar 17, 2021

Recalling firm

Becton Dickinson & Co.

Quantity

33660 EA

Product code

JTY

FDA submissions

K770287

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.

Product description

BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BD BBL™ Martin-Lewis Agar 221557

  Becton, Dickinson And Company · CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
  1 recall0 reports

Product lines

• BD BBL Martin-Lewis AgarBecton, Dickinson And Company · 2 models · 1 reports · 2 recalls

Other devices under the same FDA submission

1 device cleared under K770287 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• BD BBL™ Martin-Lewis Agar 221558

  Becton, Dickinson And Company · CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
  1 recall1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 87546).

• Z-1377-2021 · Terminated
  BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 2215…