Recalls / —
—#154393
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.
- FDA product code
- JSH — Culture Media, Non-Selective And Differential
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- 101686
Why it was recalled
Confirmed complaint of surface contamination of Listeria monocytogenes.
Root cause (FDA determination)
Material/Component Contamination
Action the firm took
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.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- 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
Timeline
- Recall initiated
- 2017-03-24
- Posted by FDA
- 2017-04-27
- Terminated
- 2017-06-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #154393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.