CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report
Envoy 500 Ise Calibrator Kit, reference recalled
ELITech Clinical Systems SAS is recalling Envoy 500 Ise Calibrator Kit, reference 55117 (contained mL Calibrator High level and mL, distributed nationwide in the US. The recall was initiated on 18 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2591-2018
- FDA event ID
- 80321
- Recalling firm
- ELITech Clinical Systems SAS, Sees, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Apr 2017
- FDA classified
- 1 Aug 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Apr 2017 | Recall initiated by company | |
| 1 Aug 2018 | Classified by FDA | +470 days |
| 8 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.
Product as listed by the FDA
ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
Where it was distributed
U.S. only. No gov. accounts. No international.
Questions about this recall
Is Envoy 500 Ise Calibrator Kit, reference 55117 (contained mL Calibrator High level and mL recalled?
Yes. ELITech Clinical Systems SAS recalled Envoy 500 Ise Calibrator Kit, reference 55117 (contained mL Calibrator High level and mL on 18 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2591-2018.
Why was it recalled?
ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.
Which lots are affected?
Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019
Where was it sold?
U.S. only. No gov. accounts. No international.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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