Z-0200-2024Class II

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

Name: Z-0200-2024 RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Creator: Randox Laboratories Ltd.
Published: 2023-09-06
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-09-06 / Open, Classified

FDA source

Randox Laboratories Ltd. began a recall of RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) on 2023-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0200-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-10-31
Recalling firm: Randox Laboratories, Limited
Product: RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Product code: CEM Electrode, Ion Specific, Potassium
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.
FDA root cause: Under Investigation by firm
Action: 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 [email protected] 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.
Quantity in commerce: 35 units
Distribution: US Nationwide distribution including Puerto Rico
Product codes and lots: GTIN: 05055273206104 Lot/Batch Number: (1) 7201-0747 7201-0423 7201-0417 7201-0353 7255-0198 7255-0172 7255-0171 7255-0129 7201-1085 7201-1086 7201-1079 7201-1080 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0482 (2)¿¿¿¿¿¿¿¿¿¿¿¿¿ 7201-0776 7201-0367 7201-0343¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ 7201-0348 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0200-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0198-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31
Z-0199-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31
Z-0200-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31
Z-0201-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31
Z-0202-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31

Product code CEM

K052914Class IIRx ImolaRandox Laboratories, Ltd. / cleared 2006-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)