Rx Imola

• • Ongoing Z-0200-2024 FDA Class II ·initiated 6 Sep 2023

  RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

• • Terminated Z-2084-2019 FDA Class II ·initiated 24 Jun 2019 ·via K052914, on the same 510(k)

  There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

• • Terminated Z-2059-2018 FDA Class II ·initiated 4 May 2018 ·via K052914, on the same 510(k)

  Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.

• • Terminated Z-0725-2017 FDA Class II ·initiated 14 Apr 2016 ·via K052914, on the same 510(k)

  According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K052914 ↗

FDA Product Code

CEM

FDA applicant

Randox Laboratories, Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Randox Laboratories Limited →