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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 August 14, 2023
Date Posted September 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-2531-2023
Recall Event ID 92880
510(K)Number K871447  
Product Classification Culture media, selective broth - Product Code JSD
Product remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Code Information UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Erica Knox
800-255-6730
Manufacturer Reason
for Recall		 On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
FDA Determined
Cause 2		 Under Investigation by firm
Action ThermoFisher SCIENTIFIC disseminated a "Medical Device Field Action Recall" to its consignees on 08/14/2023 by US mail. The notice explained the problem, the risk to health, and requested the following actions be taken: - Destroy any remaining affected product in inventory; - A review of reported test results should be evaluated by an appropriate technical expert; - Pass the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred; - Keep the notice on file. The firm will replace the product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
Quantity in Commerce 139 units (13,900 tests)
Distribution US Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JSD and Original Applicant = REMEL CO.
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