Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Catalogue No. CAL2351 & CAL10388, GTIN: 05055273200966, Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
Products Sold
Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based due to Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Se. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Recommended Action
Per FDA guidance
Consignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical services@randox.com within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to technical.services@randox.com.
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