ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. T
FDA device recall Z-0216-2016 · posted 2015-11-05 · Terminated
Recall details
- Recalling firm
- ELITech Clinical Systems SAS
- 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.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 969 systems
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-09-22
- Date posted
- 2015-11-05
- Date terminated
- 2016-03-04
- Location
- SEES, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 (K100525) | Seppim S.A.S. | 2010-12-15 |