Recall Z-0751-2024 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
| Date | Jan 18, 2024 (initiated Nov 13, 2023) |
| Status | Open, Classified |
| Reason | There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value. |
| Root cause | Under Investigation by firm |
| Action | On November 20, 2023, the firm notified customers via Medical Device Correction letter. The letter consisted of three parts. This recall record covers the third part, which concerned transcription errors in the Instructions for Use (IFU) for the above listed products. Customers should discard all copies of the IFUs and download the latest versions from www.randox.com. Customers should discuss the contents of the recall notice with their Medical Director if they have used the incorrect target value for any of the affected products. |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053153 | RANDOX CALIBRATION SERUM Randox Laboratories, Ltd., Jan 13, 2006 |