Recall Z-1759-2024
Randox Laboratories Ltd. · initiated March 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Codes / lots: Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
Reason for recall
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.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-1759-2024
- Initiated
- March 5, 2024
- Posted by FDA
- May 3, 2024
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 80,366 units (US: 242 units; OUS: 80,094 units)
- Distribution
- Domestic: Nationwide Distribution.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North