Atac 8000 Random Access Chemistry System

• • Terminated Z-2591-2018 FDA Class II ·initiated 18 Apr 2017 ·on shared 510(k) K945271

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K945271 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K924084 Active Cleared 29 Sep 1992