Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Brand
Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
Lot Codes / Batch Numbers
1306UN, 1308UN, 1309UN
Products Sold
1306UN, 1308UN, 1309UN
Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom is recalling Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for i due to The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
Recommended Action
Per FDA guidance
On May 25, 2019, the firm notified its customers of the recall via Urgent Medical Device Correction letters. Customers were instructed to do the following: " Review your reagent inventory of these products. Remove all previous versions of the Value Sheets in use and replace with the revised version. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to t echnical.services@ randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026