Z-2591-2018 Class II Terminated
FDA device recall Z-2591-2018 was initiated by ELITech Clinical Systems SAS on April 18, 2017 and is designated Class II. 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 vial… The recall status is terminated (terminated April 17, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- April 18, 2017
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
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.
Distribution Pattern
U.S. only. No gov. accounts. No international.
Code Information
Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019