Z-1876-2017Class III

BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and...

Name: Z-1876-2017 BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and...
Creator: Becton Dickinson & Co.
Published: 2015-03-27
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-03-27 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing -... on 2015-03-27. FDA classified it as Class III and gives the reason as "BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1876-2017
Classification: Class III
Status: Terminated
Initiated: 2015-03-27
Posted: 2017-04-26
Terminated: 2017-04-26
Recalling firm: Becton Dickinson & Co
Product: BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
Product code: JSG Culture Media, Non-Selective And Non-Differential
Reason for recall: BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.
FDA root cause: Under Investigation by firm
Action: Recall notification was initiated on March 27, 2015. US customers were contacted via letters sent by UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 100% of non-respondents to verify receipt of the customer letter.
Quantity in commerce: 1600 plates
Distribution: US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA
Product codes and lots: Part/Cat No. 221302 Lot / Serial No. 4365741

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1876-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1876-2017	Class III	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-25

Product code JSG

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)