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U.S. Department of Health and Human Services

Class 2 Device Recall Eon 100 system

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  Class 2 Device Recall Eon 100 system see related information
Date Initiated by Firm September 22, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on March 04, 2016
Recall Number Z-0214-2016
Recall Event ID 72322
510(K)Number K100525  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product Eon 100 system included the following product reference numbers and names:

Reference no. 77345- Glucose (GPSL)
Reference no. 77450- Uric acid (AUVD)
Reference no. 77435- Triglycerides (TGML)
Reference no. 77295- Cholesterol (CHVD)
Reference no. 77301- Cholesterol HDL (HDLL)
Reference no. 77310- Cholesterol, LDL (LDLL)

Code Information all lots
Recalling Firm/
Manufacturer		 ELITech Clinical Systems SAS
Zone lndustrielle
SEES France
For Additional Information Contact Customer Care
800-345-2822
Manufacturer Reason
for Recall		 ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm sent recall letters or Technical Bulletins to US consignees on 9/22/15 via registered mail. Technical Bulletin #1022 (for EON 100 users) Technical Bulletin #2008 (for EON 300 users) Technical Bulletin #5064 (for ENVOY users) Technical Bulletin #3009 (for Selectra users) ELITechGroup is not requesting return of the affected product. The method sheets and package inserts will be updated with the new interference claims. When available, the revised labeling will be provided to the customer for customer's use until the new IFU is included in the product packaging. Consignees are requested to return the Confirmation of Receipt form back to the firm by FAX to 401-642-9001 or send email to customercare@elitechgroup.com or send via US Post: Vital Diagnostics, 27 Wellington Rd., Lincoln, Rl. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822 or 855-ELITECH
Quantity in Commerce 1389 systems
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = SEPPIM S.A.S.
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