Z-1016-2019Class II

Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox...

Name: Z-1016-2019 Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox...
Creator: Randox Laboratories Ltd.
Published: 2018-12-03
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-12-03 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry... on 2018-12-03. FDA classified it as Class II and gives the reason as "The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1016-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-12-03
Posted: 2019-03-15
Recalling firm: Randox Laboratories, Limited
Product: Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Product code: JIT Calibrator, Secondary
Reason for recall: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm, Randox, notified the US distributor via email on 3 Dec 2018 with an "Urgent Medical Device Correction" letter dated 26 Nov 2018. The distributors and customers were instructed to remove the Value Sheet from existing stock and replace with the new Value Sheet and Important Notice. Customers were asked to take the following actions: " Please review all remaining stock and add the attached important notice to each kit. Replace the kit value sheet with the revised document provided. " Discuss the contents of this notice with your Medical Director. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form to [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services by email: [email protected] or +44 (0)28 9442 2413 or Tel: +1 304 728 2890 Toll Free 866 4 RANDOX or Email: Cheryl.O'[email protected].
Quantity in commerce: 85 kits
Distribution: US Distribution to states to: CA, ME. MI, and WV.
Product codes and lots: 498FR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1016-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1016-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-15
Z-1017-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-15
Z-1018-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-15

Product code JIT

K023763Class IIRandox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsRandox Laboratories, Ltd. / cleared 2003-01-13

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)