Recall Z-2591-2018 ยท JIX Calibrator, Multi-Analyte Mixture
ELITech Clinical Systems SAS
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
| Date | Apr 18, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Distribution | U.S. only. No gov. accounts. No international. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM Bio-Chem Laboratory Systems, Inc., Apr 20, 1995 |