Date Initiated by Firm | December 10, 2020 |
Create Date | January 14, 2021 |
Recall Status1 |
Terminated 3 on July 06, 2023 |
Recall Number | Z-0769-2021 |
Recall Event ID |
87010 |
Product Classification |
Culture media, selective and differential - Product Code JSI
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Product | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 |
Code Information |
Lot 150237 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact | Technical Services Department 800-255-6730 |
Manufacturer 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 2 | 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 1-800-255-6730 (US) or via email: microbiology.ts.us@thermofisher.com. |
Quantity in Commerce | 637 units |
Distribution | Distribution in United States -
AL, FL, GA, LA MS, NC, SC, TN |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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