Z-1333-2013Class II

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

Name: Z-1333-2013 BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing...
Creator: Becton Dickinson & Co.
Published: 2013-03-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-03-11 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms on 2013-03-11. FDA classified it as Class II and gives the reason as "Microbiological media may be contaminated with bacteria". 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-1333-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-11
Posted: 2013-05-16
Terminated: 2013-06-24
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.
Product code: JSI Culture Media, Selective And Differential
Reason for recall: Microbiological media may be contaminated with bacteria.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1333-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1332-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16
Z-1333-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16
Z-1334-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16

Product code JSI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)