Z-0839-2019Class II

Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN...

Name: Z-0839-2019 Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN...
Creator: Randox Laboratories Ltd.
Published: 2018-12-04
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-12-04 / Terminated / root cause: design

FDA source

Randox Laboratories Ltd. began a recall of Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904 on 2018-12-04. FDA classified it as Class II and gives the reason as "Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0839-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-04
Posted: 2019-02-15
Terminated: 2020-06-18
Recalling firm: Randox Laboratories, Limited
Product: Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Product code: CJY Azo Dye, Calcium
Reason for recall: Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
Root cause tag: design
FDA root cause: Device Design
Action: Randox the US distributor contacted customers by email on 12/4/18 to advise of problem and provided an update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments.The instrument testing order should be reviewed in line with the updated technical bulletin. A revised letter issued 12 Feb 2019 to advise "reagent would be observed as inconsistencies in Quality control recovery which may lead to a delay in running patient samples or erroneous elevated / depressed test results".
Quantity in commerce: 225 kits
Distribution: WV, PR
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0839-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0839-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-15
Z-0840-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-15

Product code CJY

K974607Class IIRandox CalciumRandox Laboratories, Ltd. / cleared 1998-02-02

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)