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Recall Observatory FDA recall evidence

Device product

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.

Z-0974-2015

June 06, 2014

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 69091
Status
Terminated
Classification
Class II
Quantity
7,617 cases (100 plates/case)
Official record key
device-enforcement:Z-0974-2015

Official wording

Reason: A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

Code information: Catalogue # 221291 with Lot #4050354, 4086399, 4099206 and 4143653; Catalogue #221261 with Lot # 4022158 4086443 4092199

Distribution pattern: Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination of Listeria monocytogenes