Device 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)
Z-0214-2016
Product summary
- Event
- Event 72322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1389 systems
- Official record key
device-enforcement:Z-0214-2016
Official wording
Reason: 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.
Code information: all lots
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.