Z-1559-2016Class II

Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number...

Name: Z-1559-2016 Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number...
Creator: Becton Dickinson & Co.
Published: 2016-03-28
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-03-28 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold... on 2016-03-28. FDA classified it as Class II and gives the reason as "Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media". 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-1559-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-04-22
Terminated: 2016-11-14
Recalling firm: Becton Dickinson & Co
Product: Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: 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: Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD sent an Urgent Product Recall letter dated March 2016 to all US customers via UPS or email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected lots and discard any remaining product. BD will replace the discard inventory. Customers were asked to complete and fax the attached form to : Attention Regulatory Compliance, Fax: 410-316-4258 or email to [email protected].
Quantity in commerce: 88,300 plates (883 cartons)
Distribution: US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
Product codes and lots: Cat. Number Lot Number 221291 6034889

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1559-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1559-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

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)