Z-0974-2015Class II

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep...

Name: Z-0974-2015 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep...
Creator: Becton Dickinson & Co.
Published: 2014-06-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-06-06 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious... on 2014-06-06. FDA classified it as Class II and gives the reason as "A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The...". 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-0974-2015
Classification: Class II
Status: Terminated
Initiated: 2014-06-06
Posted: 2015-01-14
Terminated: 2016-08-12
Recalling firm: Becton Dickinson & Co
Product: TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
Product code: JSI Culture Media, Selective And Differential
Reason for recall: A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000.
Quantity in commerce: 7,617 cases (100 plates/case)
Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
Product codes and lots: Catalogue # 221291 with Lot #4050354, 4086399, 4099206 and 4143653; Catalogue #221261 with Lot # 4022158 4086443 4092199

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0974-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14
Z-0975-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14
Z-0976-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)