FDA Medical Device Recalls (openFDA)
ELITech Clinical Systems SAS: ELITech 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
- Recall number
- Z-0216-2016
- Recalling firm
- ELITech Clinical Systems SAS
- Product
- ELITech 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
- Status
- Terminated
- Initiated
- 2015-09-22
- Posted
- 2015-11-05
- Terminated
- 2016-03-04
- Reason
- 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.
- Root cause
- 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
- 969 systems
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- all lots
- 510(k) numbers
- ["K100525"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 3007662974
- Firm city
- SEES
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28