Recall Z-2591-2018
ELITech Clinical Systems SAS · initiated April 18, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019
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: Under Investigation by firm
Action taken
ELITech 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.
Details
- Recall number
- Z-2591-2018
- Initiated
- April 18, 2017
- Terminated
- April 17, 2020
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Distribution
- U.S. only. No gov. accounts. No international.
- Recalling firm
- ELITech Clinical Systems SAS, Sees