Recall Z-0769-2021 ยท JSI Culture Media, Selective And Differential
Remel Inc
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
| Date | Dec 10, 2020 |
| Status | Terminated |
| Reason | The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 637 units |
| Distribution | Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.