FDA Recall Terminated

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.

Recall: Z-1876-2017 · Initiated March 27, 2015

Recall

Recall Number
Z-1876-2017
Event Number
76930
Firm
Becton Dickinson & Co.
FEI Number
1119779
Product Code
JSG
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
March 27, 2015
Terminated
April 26, 2017
Address
7 Loveton Cir, Sparks, MD, 21152-9212

Description

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.

Reason

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.

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.

Distribution

US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA

Quantity

1600 plates