Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
This recall is currently active, issued January 18, 2024. It was issued by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
- Recall Initiated
- November 13, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0751-2024
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025
Root Cause
Under Investigation by firm
Action Taken
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.