Z-2753-2020Class II

Randox Lipase Assay: Lipase Colorimetric R2 Substrate -

Name: Z-2753-2020 Randox Lipase Assay: Lipase Colorimetric R2 Substrate -
Creator: Randox Laboratories, Ltd.
Published: 2020-06-26
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2020-06-26 / Terminated

FDA source

RANDOX LABORATORIES, LTD. began a recall of Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of... on 2020-06-26. FDA classified it as Class II and gives the reason as "Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2753-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-26
Posted: 2020-08-04
Terminated: 2020-10-19
Recalling firm: Randox Laboratories, Limited
Product: Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
FDA root cause: Unknown/Undetermined by firm
Action: Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Product codes and lots: Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2753-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2751-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-04
Z-2752-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-04
Z-2753-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-04

Product code CHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)