Z-2490-2019Class III

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays...

Name: Z-2490-2019 This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays...
Creator: Randox Laboratories Ltd.
Published: 2019-07-12
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-07-12 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and... on 2019-07-12. FDA classified it as Class III and gives the reason as "Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2490-2019
Classification: Class III
Status: Terminated
Initiated: 2019-07-12
Posted: 2019-09-07
Terminated: 2020-06-17
Recalling firm: Randox Laboratories, Limited
Product: This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox Laboratories Ltd. issued Urgent Medical Device Correction letter on 7/12/19 advising users of the problem, health risk and action to take: Replace all Quality Control value sheets with the revised sheets available on www.randox.com . 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.
Quantity in commerce: 307 kits
Distribution: Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Product codes and lots: Lot Numbers: 961UE onwards GTN: 05055273200966

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2490-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2490-2019	Class III	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-07

Product code JIX

K053153Class IIRandox Calibration SerumRandox Laboratories, Ltd. / cleared 2006-01-13

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)