Device product
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Z-1888-2017
Product summary
- Firm
- Remel Inc
- Event
- Event 76846
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,159/100 plates/packs
- Official record key
device-enforcement:Z-1888-2017
Official wording
Reason: Confirmed complaint of surface contamination of Listeria monocytogenes.
Code information: 101686
Distribution pattern: US Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico
Derived failure modes
-
Microbial contamination
contamination of Listeria monocytogenes