Device recall: Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL)…
Class II FDA enforcement event 72322. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
ELITech Clinical Systems SAS started this device recall on 22 Sep 2015. The firm address in the FDA record is in SEES. FDA put the recall in Class II. FDA event 72322 has 4 product records. The first FDA enforcement report date is 11 Nov 2015. The record gives the status Terminated, with the termination date 4 Mar 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution
Recalling firm
ELITech Clinical Systems SAS, SEES, N/A, France.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0214-2016 | 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) | 1389 systems | Class II | Terminated | 11 Nov 2015 |
| Z-0215-2016 | Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL) | 612 total | Class II | Terminated | 11 Nov 2015 |
| Z-0216-2016 | 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… | 969 systems | Class II | Terminated | 11 Nov 2015 |
| Z-0217-2016 | Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500… | 13455 systems | Class II | Terminated | 11 Nov 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Apr 2017 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low le | Device | Class II | 1 |
| 11 Aug 2014 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reag | Device | Class III | 1 |
Official channels
- FDA enforcement report Z-0214-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72322. https://recallregister.com/fda/ii/72322/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution
- What quantity of product is in FDA event 72322?
- The event has 4 product records. The first record gives this quantity:
1389 systems
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.