—#154600

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.

FDA product code: JSG — Culture Media, Non-Selective And Non-Differential
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Part/Cat No. 221302 Lot / Serial No. 4365741

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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

Timeline

Recall initiated: 2015-03-27
Terminated: 2017-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.