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U.S. Department of Health and Human Services

Class 3 Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob

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  Class 3 Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob see related information
Date Initiated by Firm March 27, 2015
Create Date April 26, 2017
Recall Status1 Terminated 3 on April 26, 2017
Recall Number Z-1876-2017
Recall Event ID 76930
Product Classification Culture media, non-selective and non-differential - Product Code JSG
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.
Code Information Part/Cat No. 221302  Lot / Serial No. 4365741 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact
410-316-4000
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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