Randox Laboratories Ltd.: Calibration Serum and Multi-Sera Recalled for Incorrect Target Values

What You Should Do

1. Locate the Instructions For Use (IFU) and packaging for your Randox Calibration Serum Level 3 (REF CAL2351), specifically checking for lot numbers 1260UE (Exp 28 Nov 2024), 1262UE (Exp 28 Jan 2025), and 1315UE (Exp 28 May 2025).
2. Check your inventory for Human Assayed Multi-Sera Level 2 (REF HN1530) and Human Assayed Multi-Sera Level 3 (REF HE 1532) to see if you have the affected documentation.
3. Identify the transcription errors: for Calibration Serum Level 3, check the Bilirubin and Triglycerides target values; for Multi-Sera Level 2, check the TBIC target value; and for Multi-Sera Level 3, check the Lipase target value.
4. Contact your healthcare provider or Randox Laboratories Ltd. immediately to obtain the corrected Instructions For Use (IFU) and to determine if previous test results need to be reviewed.
5. Contact Randox Laboratories Ltd. at their headquarters or through your local distributor for further instructions and potential product replacement or documentation updates.
6. For additional questions, contact the FDA medical device recall line at 1-888-463-6332.

Your Remedy Options

Affected Products