Becton Dickinson & Co.: BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.

Recall number

Z-1333-2013

Recalling firm

Becton Dickinson & Co.

Product

BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.

Status

Terminated

Initiated

2013-03-11

Posted

2013-05-16

Terminated

2013-06-24

Reason

Microbiological media may be contaminated with bacteria.

Root cause

Material/Component Contamination

Action

BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.

Quantity

521,160 total pieces (all three recalled products)

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.

Lot, serial or model codes

Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13

510(k) numbers

not on file

PMA numbers

not on file

Product code

JSI

Firm FEI

1119779

Firm city

Sparks

Firm state

MD

Firm country

not on file

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

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