RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

FDA device recall Z-0200-2024 · posted 2023-10-31 · Open, Classified

Recall details

Recalling firm

Randox Laboratories Ltd.

Reason for recall

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.

Action taken

Randox issued Medical Device Correction letter (REC687) on 9/13/23 to to US and PR customers on 9/12/23. Letter states reason for recall, health risk and action to take: Randox recommendations: " Auto rerun settings are disabled, see Appendix A for guidance for each Rx instrument. " Results with flag(<) reported as the bottom of the technical range. Sample Volume settings Low should not be applied. " Results with flag (>) reported as the top of the technical range. Sample Volume settings high and dilutions should not be applied. A manual dilution should be performed, and results multiplied by the dilution factor. The RX Parameter rerun settings will be updated with a parameter release in due course, the Instructions For Use will also be updated at this time. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CEM

Quantity affected

35 units

Distribution

US Nationwide distribution including Puerto Rico

Date initiated

2023-09-06

Date posted

2023-10-31

Location

Crumlin, North, Ireland

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