Recalls / —

—#185037

Product

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

FDA product code

JSI — Culture Media, Selective And Differential

Device class

Class 1

Medical specialty

Microbiology

Affected lot / code info

Lot 150237

Why it was recalled

The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The recalling firm issued a recall notification letter dated 12/16/2020 to all impacted customers. The letter states that all impacted product has since expired on 12/10/2020. Customers are asked to review of reported test results should be determined by the appropriate technical expert. Customers are also asked to keep the notification letter on file. The notice should be passed on to all who need to be aware within the organization or to any organization where the potentially affected products have been transferred. Questions may be directed to the Technical Services Department at 1-800-255-6730 (US) or via email: microbiology.ts.us@thermofisher.com.

Recalling firm

Firm

Remel Inc

Address

12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern

Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN

Timeline

Recall initiated

2020-12-10

Terminated

2023-07-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #185037. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.