Z-2084-2019Class II

RX Imola, Model Nos. RX4900

Name: Z-2084-2019 RX Imola, Model Nos. RX4900
Creator: Randox Laboratories, Limited
Published: 2019-06-24
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-06-24 / Terminated

FDA source

Randox Laboratories, Limited began a recall of RX Imola, Model Nos. RX4900 on 2019-06-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2084-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-24
Posted: 2019-07-25
Terminated: 2020-05-21
Recalling firm: Randox Laboratories, Limited
Product: RX Imola, Model Nos. RX4900
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to [email protected] within five working days.
Quantity in commerce: 27
Distribution: Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2083-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-25
Z-2084-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)