Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar

FDA device recall Z-1888-2017 · posted 2017-04-27 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

Confirmed complaint of surface contamination of Listeria monocytogenes.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

JSH

Quantity affected

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

Date initiated

2017-03-24

Date posted

2017-04-27

Date terminated

2017-06-06

Location

Lenexa, KS