Z-1424-2022Class II

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog...

Name: Z-1424-2022 Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog...
Creator: Randox Laboratories Ltd.
Published: 2022-06-22
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2022-06-22 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0 on 2022-06-22. FDA classified it as Class II and gives the reason as "Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal...". 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-1424-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-22
Posted: 2022-07-20
Terminated: 2024-05-10
Recalling firm: Randox Laboratories, Limited
Product: Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Randox issued recall notification extended to the distribution center within the USA via email. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted week beginning 27 Jun 22. Letter states reason for recall, health risk and action to take: Discontinue use of and discard any of the above batches immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " 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: 15 kits
Distribution: Nationwide Distribution - MD, OR, PR, MT, WV
Product codes and lots: GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1424-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1424-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code CHH

K923504Class ICholesterol Enzymatic EndpointRandox Laboratories, Ltd. / cleared 1994-01-10

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)