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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 18, 2017
Create DateAugust 01, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall NumberZ-2591-2018
Recall Event ID 80321
510(K)NumberK945271 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductENVOY 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
Code Information Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019 
FEI Number 3007662974
Recalling Firm/
Manufacturer		 ELITech Clinical Systems SAS
Zone Industrielle des Fourneaux
Sees France
For Additional Information Contact
3812102
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionELITech Clinical Systems SAS notified consignees on April 18, 2018 via USPS certified letter, dated April 10, 2018 titled Product Recall Notice. The Product Recall Notice provided customers/consignees reason for recall, actions to be taken, and included a confirmation of receipt of product recall notice form to be filled out and returned by customer/consignee.
DistributionU.S. only. No gov. accounts. No international.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JIX
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