Z-0328-2022Class II

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Name: Z-0328-2022 RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Creator: Randox Laboratories Ltd.
Published: 2021-11-01
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2021-11-01 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 on 2021-11-01. FDA classified it as Class II and gives the reason as "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". 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-0328-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-01
Posted: 2021-12-01
Terminated: 2023-03-09
Recalling firm: Randox Laboratories, Limited
Product: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take: Action to be taken: " 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. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.
Quantity in commerce: 15 kits
Distribution: US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Product codes and lots: Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0328-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0328-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-01

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)