Recall Z-0769-2021
Remel Inc · initiated December 10, 2020
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