Recall Z-1888-2017 ยท JSH Culture Media, Non-Selective And Differential
Remel Inc
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.
| Date | Apr 27, 2017 (initiated Mar 24, 2017) |
| Status | Terminated |
| Reason | Confirmed complaint of surface contamination of Listeria monocytogenes. |
| Root cause | Material/Component Contamination |
| Action | On 3/24/2017, the recalling firm sent a recall notice to their customers explaining the reason for the recall and instructing customers to review their stock and discard any affected product. The notice also instructed customers to advise of the recall anyone they may have further distributed the recalled lot to. Attached to the recall notice is a response form which the recalling firm instructed their consignees to fill out and return. |
| Quantity | 1,159/100 plates/packs |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.