Z-2059-2018Class II

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical...

Name: Z-2059-2018 RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical...
Creator: Randox Laboratories
Published: 2018-05-04
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-05-04 / Terminated / root cause: software

FDA source

Randox Laboratories began a recall of RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests on 2018-05-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2059-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-06-04
Terminated: 2020-06-16
Recalling firm: Randox Laboratories, Limited
Product: RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.
Quantity in commerce: 41 analyzers
Distribution: US Distribution including Puerto Rico and the state of : West Virginia.
Product codes and lots: GTIN 05055273206104. All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2059-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2059-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-04

Product code JJE

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)