Z-1876-2017 Class III Terminated
FDA device recall Z-1876-2017 was initiated by Becton Dickinson & Co. on Mar 27, 2015 and is designated Class III. 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… The recall status is terminated (terminated Apr 26, 2017). Affected quantity: 1600 plates.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2017
- Initiation Date
- Mar 27, 2015
- Termination Date
- Apr 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1600 plates
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.
Distribution Pattern
US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA
Code Information
Part/Cat No. 221302 Lot / Serial No. 4365741
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1876-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026