The Recall Desk
HighFDA (Devices)·Z-0328-2022·Announced 2021-12-08

Cholesterol test system recalled due to calibration failure

RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a calibration defect that affects test accuracy. While no illnesses or injuries are reported in the source, the device provides inaccurate measurements that could lead to misdiagnosis and improper patient treatment—a risk-of-harm scenario where injury has not yet been documented.

Plain-English summary

The U.S. Food and Drug Administration is notifying users of a recall of the RANDOX CHOL cholesterol test system (Reference CH200), intended for measuring total cholesterol in blood plasma and serum samples. Two lot numbers are affected: 559344 (expiration 28th June 2022) and 572730 (expiration 28th July 2023). The product was distributed nationwide to laboratories and medical facilities in Georgia, Oregon, Pennsylvania, Washington, and West Virginia.

The test system is being recalled because of a calibration defect. When calibrating with the standard provided in the kit, the change in absorbance is lower than expected, causing the internal quality control results to be flagged as high and outside the acceptable range. A calibration failure of this nature can compromise the accuracy of cholesterol measurements.

Laboratories and medical facilities that received this product should immediately discontinue use and contact Randox Laboratories Ltd. for instructions regarding return or replacement of affected test kits.

The recalled product

Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Manufacturer
Randox Laboratories Ltd.
Category
Medical Device — Laboratory Testing
Hazard
  • calibration-failure
  • inaccurate-test-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers/Exp Date: 559344 28th June 2022
  • 572730 28th July 2023. GTIN: 05055273201130

Distribution

Distributed nationwide across the United States.

Related recalls

Same category