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U.S. Department of Health and Human Services

Class 2 Device Recall Remel

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  Class 2 Device Recall Remel see related information
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
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
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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