Recall Z-1876-2017— Becton Dickinson & Co.
Class III · Terminated
Class III FDA medical device recall by Becton Dickinson & Co., initiated 2015-03-27, terminated 2017-04-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-03-27
- Terminated
- 2017-04-26
- Firm location
- Sparks, MD, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.