Recall Z-0769-2021

Remel Inc · initiated December 10, 2020

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Lot 150237

Reason for recall

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

FDA-determined cause: Mixed-up of materials/components

Action taken

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.

Details

Recall number
Z-0769-2021
Initiated
December 10, 2020
Terminated
July 6, 2023
Product code
JSI – Culture Media, Selective And Differential
Quantity
637 units
Distribution
Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
Recalling firm
Remel Inc, Lenexa, KS

Official FDA recall record