ELITech Recalls ENVOY 500 ISE Calibrator Kits Due to Calibration Failures
ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The primary hazard is a delay in patient results due to equipment malfunction, which fits the criteria for a moderate severity recall involving low-risk operational issues.
Plain-English summary
ELITech Clinical Systems SAS is recalling the ENVOY 500 ISE Calibrator Kit, reference 55117. The affected lot number is 7038, with a manufacture date of 03/2017 and an expiration date of 02/2019. The product was distributed in the United States only.
The recall was initiated because users of the Envoy 500 systems reported trouble calibrating with some vials from this lot. Users received error messages such as "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE," indicating failed calibration. This issue has resulted in delays in obtaining patient results until the calibrator lot is replaced.
Users of the affected product should stop using the calibrator lot and contact ELITech Clinical Systems for replacement or further instructions.
The recalled product
- Product
- 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
- Manufacturer
- ELITech Clinical Systems SAS
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number 7038
- Manufacture date 03/2017
- Expiration date 02/2019
Distribution
Distribution scope not specified by the agency.
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