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U.S. Department of Health and Human Services

Class 2 Device Recall Selectra ProS and ProM systems

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 Class 2 Device Recall Selectra ProS and ProM systemssee related information
Date Initiated by FirmSeptember 22, 2015
Date PostedNovember 05, 2015
Recall Status1 Terminated 3 on March 04, 2016
Recall NumberZ-0216-2016
Recall Event ID 72322
510(K)NumberK100525 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G
Code Information all lots
Recalling Firm/
Manufacturer		 ELITech Clinical Systems SAS
Zone lndustrielle
SEES France
For Additional Information ContactCustomer Care
800-345-2822
Manufacturer Reason
for Recall		ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce969 systems
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
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