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)
FDA Recall Z-0214-2016 · Posted 2015-11-05
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Recalling FirmELITech Clinical Systems SAS
Recall StatusTerminated
Product CodeCGA
Date Initiated2015-09-22
Date Terminated2016-03-04
Product Quantity1389 systems
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.
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 [email protected] 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
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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